Company · US
Abbott Vascular
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2022. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
49recalls (0 in 12 months)
37recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 26 |
| DQX | Wire, Guide, Catheter | 21 |
| MAV | Syringe, Balloon Inflation | 10 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 8 |
| NKM | Mitral Valve Repair Devices | 5 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 5 |
| DQY | Catheter, Percutaneous | 4 |
| DRA | Catheter, Steerable | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 |
| NIM | Stent, Carotid | 3 |
| DYB | Introducer, Catheter | 2 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| MGB | Device, Hemostasis, Vascular | 1 |
| NIQ | Coronary Drug-Eluting Stent | 1 |
| PNY | Absorbable Coronary Drug-Eluting Stent | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2022 | K220634 | NC TREK NEO Coronary Dilatation Catheter Abbott Vascular | LOX |
| May 5, 2022 | K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter Abbott Vascular | LIT |
| Jul 30, 2020 | K201834 | HI-TORQUE PROCEED Guide Wire Family Abbott Vascular | DQX |
| Apr 8, 2020 | K200144 | HI-TORQUE Steelcore Bare Guide Wire Abbott Vascular | DQX |
| Dec 11, 2019 | K193126 | HI-TORQUE InfilTrac Guide Wire Family Abbott Vascular | DQX |
| Jul 25, 2019 | K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires Abbott Vascular | NTE |
| Aug 24, 2018 | K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Cathet Abbott Vascular | LOX |
| Jan 12, 2018 | K173795 | HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular | DQX |
| Sep 6, 2017 | K172394 | Steerable Guide Catheter Abbott Vascular | DRA |
| Aug 25, 2017 | K172073 | Hi-Torque Command 18 Guide Wire Abbott Vascular | DQX |
| Aug 7, 2016 | K161985 | Steerable Guide Catheter Abbott Vascular | DRA |
| Nov 20, 2015 | K153086 | RX ACCUNET Embolic Protection System Abbott Vascular | NTE |
| Oct 21, 2015 | K152709 | HI-TORQUE BALANCE Abbott Vascular | DQX |
| Sep 21, 2015 | K152404 | Hi-Torque Command 18 Guide Wire Abbott Vascular | DQX |
| Jul 6, 2015 | K151317 | Armada 18 PTA Catheter Abbott Vascular | LIT |
| Dec 19, 2014 | K142415 | Hi-Torque JET Guide Wire Family Abbott Vascular, Inc. | DQX |
| Aug 7, 2014 | K141782 | HI-TORQUE VERSATURN GUIDE WIRE Abbott Vascular | DQX |
| Jul 22, 2014 | K141678 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular | NTE |
| Jan 30, 2013 | K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN Abbott Vascular | LOX |
| Jan 29, 2013 | K123067 | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY Abbott Vascular, Inc. | DQX |
| Nov 20, 2012 | K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY Abbott Vascular, Inc. | DQX |
| Aug 15, 2012 | K121352 | ARMADA 14XXT PTA CATHETER Abbott Vascular | DQY |
| Jun 22, 2012 | K121222 | TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER Abbott Vascular | LOX |
| May 4, 2012 | K121015 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular | NTE |
| Mar 6, 2012 | K113464 | NC TREK OTW CORONARY DILATATION CATHETER Abbott Vascular | LOX |
| Oct 3, 2011 | K111899 | ARMADA 35/35LL PTA CATHETER Abbott Vascular | LIT |
| Aug 31, 2011 | K112239 | STEERABLE GUIDE CATHETER Abbott Vascular | DRA |
| Jun 2, 2011 | K110617 | MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER Abbott Vascular | LOX |
| Dec 7, 2010 | K102705 | ARMADA 14 PTA CATHETER Abbott Vascular, Inc. | LIT |
| Jul 8, 2010 | K101648 | HI-TORQUE WINN GUIDE WIRE FAMILY Abbott Vascular, Inc. | DQX |
| May 24, 2010 | K101011 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Abbott Vascular, Inc. | DQX |
| Sep 25, 2009 | K091825 | HI-TORQUE PROGRESS GUIDE WIRE FAMILY Abbott Vascular, Inc. | DQX |
| Aug 27, 2009 | K092286 | FOX SV PTA CATHETER Abbott Vascular | LIT |
| Mar 11, 2009 | K083738 | HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 Abbott Vascular | DQX |
| Feb 25, 2009 | K083732 | TAD AND TAD II TAPERED GUIDE WIRES Abbott Vascular | DQX |
| Feb 23, 2009 | K083713 | .035 LOC GUIDE WIRE EXTENSION Abbott Vascular | DQX |
| Feb 6, 2009 | K083706 | HI-TORQUE VERSACORE GUIDE WIRE Abbott Vascular | DQX |
| Jun 4, 2008 | K081417 | FOXCROSS PTA CATHETER Abbott Vascular, Inc. | LIT |
| Apr 28, 2008 | K080925 | FOX PLUS PTA CATHETER Abbott Vascular, Inc. | LIT |
| Apr 11, 2008 | K072460 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE Abbott Vascular, Inc. | DQX |
| Sep 14, 2007 | K063481 | MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM Abbott Vascular, Inc. | FGE |
| Feb 6, 2007 | K062554 | STARCLOSE HEX-HUB DILATOR Abbott Vascular, Inc. | DRE |
| Jul 7, 2006 | K060902 | STARCLOSE INTRODUCER SET MODEL- 1002 Abbott Vascular, Inc. | DYB |
| Oct 22, 2003 | K032929 | MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 Abbott Vascular, Inc. | FGE |
| Aug 12, 2003 | K031331 | WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM Abbott Vascular, Inc. | FGE |
| Aug 23, 2002 | K021062 | CHITO-SEAL Abbott Vascular, Inc. | QSY |
| Jan 11, 2002 | K014118 | MODIFICATION TO SUPERCROSS CATHETER Abbott Vascular, Inc. | DQY |
| Dec 6, 2001 | K013683 | MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE Abbott Vascular, Inc. | GAW |
| Mar 7, 2001 | K001856 | SUPERCROSS CATHETER Abbott Vascular, Inc. | DQY |
| Oct 3, 2000 | K001703 | PERCLOSE VASCULAR SUTURE DELIVERY DEVICE Abbott Vascular, Inc. | GAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | Abbott Vascular Inc 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. Open, Classified |
MAV | K961471 |
| Dec 20, 2024 | Abbott Vascular Inc 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures. Open, Classified |
MAV | K961471 |
| Dec 20, 2024 | Abbott Vascular Inc 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, atherect Open, Classified |
MAV | K961471 |
| Dec 20, 2024 | Abbott Vascular Inc 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. Open, Classified |
MAV | K961471 |
| Oct 20, 2022 | Abbott Vascular Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT,
MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW,
MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT,
MitraClip G4 CDS XTW REPAIR-MR Open, Classified |
NKM | None listed |
| Oct 20, 2022 | Abbott Vascular Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR,
MitraClip NTR Clip Delivery System CE/CDS0602-NTR,
MitraClip XTR Clip Delivery System CE/CDS0602-XTR,
MitraClip G4 Clip Delivery System Open, Classified |
NKM | None listed |
| Oct 20, 2022 | Abbott Vascular Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR,
MitraClip G4 Clip Delivery System NT US/CDS0701-NT,
MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW,
MitraClip G4 Clip Delivery Sy Open, Classified |
NKM | None listed |
| May 19, 2022 | Abbott Vascular Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO Open, Classified |
DQO | K192019 |
| Mar 11, 2022 | Abbott Vascular Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01)
Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01) Open, Classified |
MAV | K962495 |
| Mar 11, 2022 | Abbott Vascular INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) Open, Classified |
MAV | K962495 |
| Mar 11, 2022 | Abbott Vascular 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) Open, Classified |
MAV | K961471 |
| Mar 11, 2022 | Abbott Vascular 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01)
20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01) Open, Classified |
MAV | K961471 |
| Mar 11, 2022 | Abbott Vascular 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) Open, Classified |
MAV | K961471 |
| Mar 25, 2020 | Abbott Vascular Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A, Terminated |
NIQ | None listed |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United St Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United St Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United S Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United S Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United St Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | K103153 K110134 |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | K103153 K110134 |
| May 1, 2019 | Abbott Vascular Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only Terminated |
NKM | None listed |
| Jul 3, 2018 | Abbott Vascular PLUS 30 PRIORITY PACK Accessory Kit
Product Usage:
Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters Terminated |
MAV | K962495 |
| Jun 1, 2017 | Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia).
The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially f Terminated |
PNY | None listed |
| May 12, 2017 | Abbott Vascular NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T,
1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T,
1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T,
1012451-08T, 1012451-12T, 1012451-15T, Terminated |
LOX | K103153 |
| May 12, 2017 | Abbott Vascular NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1 Terminated |
LOX | K103153 |
| May 12, 2017 | Abbott Vascular NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 101245 Terminated |
LOX | K103153 |
| Feb 10, 2017 | Abbott Vascular StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02.
The UDI is 08717648079467.
The GMDN is 47411. Terminated |
MGB | None listed |
| Mar 7, 2016 | Abbott Vascular MitraClip Clip Delivery System, product number MSK0101. The MitraClip System
contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product nu Terminated |
NKM | None listed |
| Dec 20, 2013 | Abbott Vascular, Inc. 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 Terminated |
DQX | None listed |
| Jan 31, 2013 | Abbott Vascular Brand Name: RX Accunet Embolic Protection System
Common Name: RX Accunet EPS.
Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55.
The RX Accu Terminated |
NTE | K081549 |
| Sep 25, 2012 | Abbott Vascular Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature. Terminated |
LIT | K111899 |
| Jul 12, 2011 | Abbott Vascular Guidant RAPIDO Cut-Away Guiding Catheter, 6F.
Part Numbers: 66676-201 and 667552-100.
For use in cardiac diagnostic and therapeutic procedures. Terminated |
DQY | K021455 K031459 +3 |
| Jul 12, 2011 | Abbott Vascular Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve
Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures. Terminated |
DTL | K991102 |
| Jul 12, 2011 | Abbott Vascular Abbott Vascular ACS .035 Torque Device
Part Number : 1003279.
For use in cardiac diagnostic or therapeutic procedures. Terminated |
DQX | K950752 |
| Nov 10, 2010 | Abbott Vascular RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061
The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection Terminated |
NIM | None listed |
| Nov 10, 2010 | Abbott Vascular RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061
The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection sy Terminated |
NIM | None listed |
| Nov 10, 2010 | Abbott Vascular RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361
The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection sys Terminated |
NIM | None listed |
| Mar 8, 2007 | Abbott Vascular, Inc. StarClose Vascular Closure System (Clip Applier & Exchange System),
Catalog Number: 14677;
Product is manufactured by:
Abbott Vascular Inc.,
400 Saginaw Drive,
Redwood City, CA 94063 Terminated |
DYB | K060902 |