Abbott Vascular, Inc.
Abbott Vascular, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2014, with 5 FDA device recalls on record.
Top product codes for Abbott Vascular, Inc.
FDA recalls by Abbott Vascular, Inc.
- Z-0731-2025 — 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
- Z-0730-2025 — 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
- Z-0732-2025 — 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
- Z-0733-2025 — 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
- Z-0558-2014 — HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM
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.
Recent clearances by Abbott Vascular, Inc.
- K142415 — Hi-Torque JET Guide Wire Family
- K123067 — PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
- K122573 — HI-TORQUE COMMAND GUIDE WIRE FAMILY
- K102705 — ARMADA 14 PTA CATHETER
- K101648 — HI-TORQUE WINN GUIDE WIRE FAMILY
- K101011 — HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
- K091825 — HI-TORQUE PROGRESS GUIDE WIRE FAMILY
- K081417 — FOXCROSS PTA CATHETER
- K080925 — FOX PLUS PTA CATHETER
- K072460 — HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
- K063481 — MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
- K062554 — STARCLOSE HEX-HUB DILATOR
- K060902 — STARCLOSE INTRODUCER SET MODEL- 1002
- K032929 — MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
- K031331 — WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
- K021062 — CHITO-SEAL
- K014118 — MODIFICATION TO SUPERCROSS CATHETER
- K013683 — MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
- K001856 — SUPERCROSS CATHETER
- K001703 — PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.