ABBOTT MEDICAL
FDA 510(k) medical device clearances.
Name variants for ABBOTT MEDICAL
as filed with FDA- ABBOTT MEDICAL
- Abbott Medical
Top product codes for ABBOTT MEDICAL
Recent clearances by ABBOTT MEDICAL
- K262006 — EnSite X EP System
- K261631 — Amplatzer TorqVue Exchange System
- K253459 — OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
- K260212 — EnSite X EP System
- K253907 — Disposable Radiofrequency Cannula
- K260499 — Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
- K252512 — Armada 14 NC PTA Catheter
- K253516 — Assert-IQ (DM5100)
- K252417 — Amplatzer Piccolo Delivery System (9-PDS-04F-045)
- K253232 — Seguin Annuloplasty Ring
- K250031 — Amplatzer Guidewire
- K252013 — EnSite X EP System
- K251463 — EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
- K251234 — EnSite X EP System
- K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
- K251211 — ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
- K251231 — ViewFlex X ICE Catheter, Sensor Enabled
- K250426 — Amulet Steerable Delivery Sheath
- K243549 — JETi Hydrodynamic Thrombectomy System
- K243224 — MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)
- K243493 — Agilis NxT Steerable Introducer Dual-Reach
- K240997 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K241538 — TriClip Steerable Guide Catheter
- K242016 — EnSite X EP System
- K241372 — Advisor HD Grid X Mapping Catheter, Sensor Enabled
- K241370 — Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
- K234118 — CentriMag Acute Circulatory Support System
- K232458 — JETiHydrodynamic Thrombectomy System
- K232690 — Amulet Steerable Delivery Sheath
- K232386 — ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
- K231415 — EnSite X EP System
- K231588 — ViewFlex Eco Reprocessed ICE Catheter
- K231311 — CPS Direct Universal slittable outer guide catheter (DS2C029)
- K230286 — Assert-IQ Insertable Cardiac Monitor
- K230934 — ViewFlex Eco Reprocessed ICE Catheter
- K230411 — Dragonfly OpStar Imaging Catheter
- K230283 — Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
- K223094 — EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License
- K222217 — ViewFlex Xtra Reprocessed ICE Catheter
- K221397 — MitraClip G4 Steerable Guide Catheter
- K221750 — CPS AIM Universal II Slittable Inner Catheter
- K220243 — Ultiri Measurement System
- K213494 — Aveir Retrieval Catheter
- K220340 — Amplatzer Steerable Delivery Sheath
- K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS
- K213364 — EnSite X EP System
- K212026 — Amplatzer Steerable Delivery Sheath
- K212738 — Amplatzer Talisman Delivery Sheath
- K211989 — Aveir Introducer
- K210458 — OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
- K202066 — EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
- K201610 — IonicRF Generator
- K201148 — EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
- K201181 — EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
- K192267 — ILUMIEN System with AptiVue Software version D.3
- K192019 — Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
- K192037 — Advisor VL Circular Mapping Catheter, Sensor Enabled
- K190581 — Amplatzer Trevisio Intravascular Delivery System
Data sourced from openFDA. This site is unofficial and independent of the FDA.