Balt USA, LLC

• QJP — Cardiovascular6 devices
• HCG — Neurology5 devices
• KRA — Cardiovascular2 devices
• NRY — Cardiovascular2 devices
• DQY — Cardiovascular1 device
• KRD — Cardiovascular1 device
• MJN — Cardiovascular1 device
• MOF — Cardiovascular1 device

• Z-0188-2026 — Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a componentClass I·Ongoing·2025-09-25
• Z-1989-2025 — Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 00810068567410 PRES0420CPKPLT 00810068567489 PRES0517CPKPLT 00810068567519 PRES0540CPKPLT 00810068568028 PRES0620CPKPLT 00810068567557 PRES0635CPKPLT 00810068567564 PRES0650CPKPLT 00810068567571 PRES0720CPKPLT 00810068567588 PRES0735CPKPLT 00810068567595 PRES0750CPKPLT 00810068567601 PRES0830CPKPLT 00810068567618 PRES0845CPKPLT 00810068567625 PRES0153HXPPL 00818053027147 PRES0204HXPPL 00818053029943 PRES0204CXPPL 00818053027321 PRES0208HXPPL 00818053029981 PRES0315HXPPL 00818053027178 PRES0307CXPPL 00818053027376 PRES0420HPKPL 00818053027185 PRES0440HPKPL 00810068567830 PRES0520HPKPL 00818053027192 PRES0540HPKPL 00810068567847 PRES0650HPKPL 00810068567854 PRES0720HPKPL 00818053027215 PRES0750HPKPL 00810068567861 PRES0830HPKPL 00818053027222 The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.Class II·Ongoing·2025-05-08
• Z-1988-2025 — Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.Class II·Ongoing·2025-05-08
• Z-1041-2024 — Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 OptiClass II·Ongoing·2024-01-03
• Z-1042-2024 — The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the anomaly, and thrombosing the target site. The Prestige Coil System is comprised of the implant coil and a pusher assembly. There are a total of 81 Prestige coil models. Vascular Embolization Device Prestige Coil Model Numbers and Product description: PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES1137COM18 Prestige Coil 11mm x 37cm Complex-18 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack PRES0210CXP10 Prestige Coil 2mm x 10cm Complex-10 Xtra Pack PRES0258CXP10 Prestige Coil 2.5mm x 8cm Complex-10 Xtra Pack PRES0417CPK10 Prestige Coil 4mm x 17cm Complex-10 Xtra Pack PRES0520CPK10 Prestige Coil 5mm x 20cm Complex-10 Xtra Pack PRES0615CPK10 Prestige Coil 6mm x 15cm Complex-10 Xtra Pack PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES2525HXPPL Prestige Coil 2.5mm x 2.5cm Prestige Plus Helical Xtra Pac PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CRG10 Prestige Coil 4mm x 13cm Complex 10 Regular PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0306HPK10 Prestige Coil 3mm x 6cm Helical-10 Pack PRES0310HPK10 Prestige Coil 3mm x 10cm Helical-10 Pack PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack PRES0930HClass II·Ongoing·2024-01-03
• Z-0103-2023 — Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.Class II·Ongoing·2022-09-07
• Z-1680-2022 — Optima Coil System Model OPTI0520CSF10. For endovascular embolization.Class II·Ongoing·2022-07-26
• Z-0660-2022 — The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.Class II·Ongoing·2022-01-04

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K260199 — SLIM MicrocatheterCode QJP·2026-07-13
• K254223 — Next Generation 088 CatheterCode QJP·2026-04-16
• K254221 — Optima Coil System (OptiOne Coil System)Code HCG·2026-01-27
• K252569 — Carrier XL Delivery CatheterCode QJP·2025-10-22
• K252700 — Optima Coil System (Optima Packing Coil System)Code HCG·2025-09-26
• K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing SetCode NRY·2025-06-03
• K251383 — Prestige Coil System (Prestige Packing Line Extension)Code KRD·2025-05-30
• K242376 — Next Generation Access PlatformCode QJP·2024-12-30
• K242582 — Optima Coil System (OptiBlock Line Extension)Code HCG·2024-09-27
• K234074 — Next Generation Access CatheterCode QJP·2024-07-02
• K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing SetCode NRY·2024-07-02
• K230609 — NG Delivery CatheterCode QJP·2023-09-13
• K223386 — Optima Coil SystemCode HCG·2022-12-06
• K213435 — MAGIC Flow-Dependent MicrocatheterCode KRA·2022-07-19
• K202366 — MAGIC Infusion CatheterCode KRA·2021-01-29
• K200030 — Optima Coil SystemCode HCG·2020-02-01
• K183045 — Eclipse 2LCode MJN·2019-04-30
• K182918 — Ballast 088 Long SheathCode DQY·2019-03-21
• K182337 — HYBRID GuidewireCode MOF·2018-10-04