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Data / Medical devices / United States / Abbott Vascular

Abbott Vascular: FDA-registered device maker in Santa Clara, CA, United States, 59 510(k) clearances and 11 PMA approvals

Abbott Vascular is registered with the FDA (registration 2939561) in Santa Clara, CA, United States. It lists 24 device types. The FDA files 59 510(k) clearances and 11 PMA approvals under its listings, the newest dated February 13, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Abbott Vascular
FDA registration number
2939561
FEI number
3004635528
Address
3200 Lakeside Dr, Santa Clara, CA, United States, 95054
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Specification developer
First device listed
June 23, 2004
Registered through
2026
Brand names listed
20/30 Indeflator, 20/30 PPAK w/COPILOT, 20/30 PPAK with Bleedback Control Valve, Abbott Medical Epicardial Cable, Abbott Medical Patient Cable, Abbott Medical Threshold Cable, Absolute Pro 35 Biliary Self-Expanding Stent System, Absolute Pro Self-Expanding Stent System and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Specification developeraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Specification developeraccessdata.fda.gov
Cardiovascular Delivery Catheter System Positioning And Stabilization DeviceQWA1Specification developeraccessdata.fda.gov
Catheter, Angioplasty, Peripheral, TransluminalLIT2Specification developeraccessdata.fda.gov
Catheter, Flow DirectedDYG2Specification developeraccessdata.fda.gov
Catheter, PercutaneousDQY2Specification developeraccessdata.fda.gov
Catheter, SteerableDRA2Specification developeraccessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX2Specification developeraccessdata.fda.gov
Coronary Covered StentNIVfSpecification developeraccessdata.fda.gov
Coronary Drug-Eluting StentNIQ3Specification developeraccessdata.fda.gov
Device, Hemostasis, VascularMGB3Specification developeraccessdata.fda.gov
Electrode, Pacemaker, TemporaryLDF2Specification developeraccessdata.fda.gov
Introducer, CatheterDYB2Specification developeraccessdata.fda.gov
Mitral Valve Repair DevicesNKM3Specification developeraccessdata.fda.gov
Scaffold, Infrapopliteal, AbsorbableNXW3Specification developeraccessdata.fda.gov
Stent, CarotidNIM3Specification developeraccessdata.fda.gov
Stent, CoronaryMAF3Specification developeraccessdata.fda.gov
Stent, IliacNIO3Specification developeraccessdata.fda.gov
Stent, RenalNIN3Specification developeraccessdata.fda.gov
Stent, Superficial Femoral ArteryNIP3Specification developeraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Specification developeraccessdata.fda.gov
Syringe, Balloon InflationMAV2Specification developeraccessdata.fda.gov
Temporary Carotid Catheter For Embolic CaptureNTE2Specification developeraccessdata.fda.gov
Wire, Guide, CatheterDQX2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 13, 2026K252512Armada™ 14 NC PTA CatheterLITSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
November 6, 2024K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQXSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
June 30, 2022K220634NC TREK NEO Coronary Dilatation CatheterLOXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
May 5, 2022K221057Viatrac 14 Plus Peripheral Dilatation CatheterLITSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
July 30, 2020K201834HI-TORQUE PROCEED Guide Wire FamilyDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
April 8, 2020K200144HI-TORQUE Steelcore Bare Guide WireDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
December 11, 2019K193126HI-TORQUE InfilTrac Guide Wire FamilyDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
July 25, 2019K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTESubstantially EquivalentAbbott Vascularaccessdata.fda.gov
May 29, 2019K190167MitraClip G4 Steerable Guide CatheterDRASubstantially EquivalentAbbottaccessdata.fda.gov
August 24, 2018K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation CatheterLOXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
January 12, 2018K173795HI-TORQUE TurnTrac Guide Wire FamilyDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
September 6, 2017K172394Steerable Guide CatheterDRASubstantially EquivalentAbbott Vascularaccessdata.fda.gov
August 25, 2017K172073Hi-Torque Command 18 Guide WireDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
November 22, 2016K161873Pacel Flow Directed Pacing CatheterLDFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
October 22, 2015K152784Pacel Bipolar Pacing CathetersLDFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
October 21, 2015K152709HI-TORQUE BALANCEDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
July 6, 2015K151317Armada 18 PTA CatheterLITSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
August 7, 2014K141782HI-TORQUE VERSATURN GUIDE WIREDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
January 30, 2013K123279MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDINLOXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
January 29, 2013K123067PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILYDQXSubstantially EquivalentAbbott Vascular, Inc.accessdata.fda.gov
November 20, 2012K122573HI-TORQUE COMMAND GUIDE WIRE FAMILYDQXSubstantially EquivalentAbbott Vascular, Inc.accessdata.fda.gov
August 15, 2012K121352ARMADA 14XXT PTA CATHETERDQYSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
March 6, 2012K113464NC TREK OTW CORONARY DILATATION CATHETERLOXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
November 8, 2011K112957HI-TORQUE POWERTURNDQXSubstantially EquivalentAbbott Vascular-Cardiac Therapiesaccessdata.fda.gov
October 3, 2011K111899ARMADA 35/35LL PTA CATHETERLITSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
February 11, 2011K110134NC TREK RX CORONARY DILATATION CATHETERLOXSubstantially EquivalentAbbott Vascular-Cardiac Therapiesaccessdata.fda.gov
February 10, 2011K103101HI-TORQUE BALANCE MIDDLEWEIGHT ELITEDQXSubstantially EquivalentAbbott Vascular-Cardiac Therapiesaccessdata.fda.gov
January 10, 2011K103110MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETERLOXSubstantially EquivalentAbbott Vascular-Cardiac Therapiesaccessdata.fda.gov
December 30, 2010K103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERLOXSubstantially EquivalentAbbott Vascular-Cardiac Therapiesaccessdata.fda.gov
December 7, 2010K102705ARMADA 14 PTA CATHETERLITSubstantially EquivalentAbbott Vascular, Inc.accessdata.fda.gov
July 8, 2010K101648HI-TORQUE WINN GUIDE WIRE FAMILYDQXSubstantially EquivalentAbbott Vascular, Inc.accessdata.fda.gov
June 23, 2010K101116HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITHDQXSubstantially EquivalentAbbott Vascular-Cardiac Therapiesaccessdata.fda.gov
March 11, 2009K083738HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05DQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
February 25, 2009K083732TAD AND TAD II TAPERED GUIDE WIRESDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
February 6, 2009K083706HI-TORQUE VERSACORE GUIDE WIREDQXSubstantially EquivalentAbbott Vascularaccessdata.fda.gov
August 18, 2008K072708ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEMFGEUnknownAbbott Vascular-Vascular Solutionsaccessdata.fda.gov
April 11, 2008K072460HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIREDQXSubstantially EquivalentAbbott Vascular, Inc.accessdata.fda.gov
March 6, 2006K053454RX HERCULINK ELITE BILIARY STENT SYSTEMFGEUnknownGuidant Corporationaccessdata.fda.gov
October 28, 1999K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
June 9, 1999K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTLSubstantially EquivalentGuidant Corp.accessdata.fda.gov
March 25, 1999K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQXSubstantially EquivalentGuidant Corp.accessdata.fda.gov
March 8, 1999K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQXSubstantially EquivalentGuidant Corp.accessdata.fda.gov
November 10, 1998K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQXSubstantially EquivalentGuidant Corp.accessdata.fda.gov
March 20, 1998K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQXSubstantially EquivalentGuidant Corp.accessdata.fda.gov
March 13, 1998K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILICDQXSubstantially EquivalentGuidant Corp.accessdata.fda.gov
August 25, 1997K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQXSubstantially EquivalentGuidant Corp.accessdata.fda.gov
January 22, 1997K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
May 8, 1996K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAVUnknownAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
May 15, 1995K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
April 5, 1995K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
April 13, 1994K934624ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVEDYBSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
December 16, 1993K934602ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIREDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
December 9, 1993K934339LOC GUIDE WIRE EXTENSIONDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
June 4, 1993K931171DOC-TITE(TM) GUIDE WIRE EXTENSIONDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
October 28, 1991K913631.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIREDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
October 23, 1991K913353VASCULAR GUIDE WIREDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
May 7, 1991K910645DISPOSABLE PATIENT CABLEDSASubstantially EquivalentDiag Corp.accessdata.fda.gov
August 3, 1988K881897ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GWDQXSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov
December 4, 1985K854261ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVESDTLSubstantially EquivalentAdvanced Cardiovascular Systems, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
April 26, 2024P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW19September 24, 2026accessdata.fda.gov
March 28, 2014P120020SUPERA PERIPHERAL STENT SYSTEMNIP36March 20, 2026accessdata.fda.gov
October 24, 2013P100009MITRACLIP DELIVERY SYSTEMNKM82June 25, 2026accessdata.fda.gov
July 31, 2012P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO14January 12, 2026accessdata.fda.gov
February 22, 2012P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO25October 22, 2025accessdata.fda.gov
November 1, 2011P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ134October 1, 2026accessdata.fda.gov
July 20, 2011P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN21October 22, 2025accessdata.fda.gov
December 21, 2005P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB49April 17, 2026accessdata.fda.gov
September 6, 2005P040038XACT CAROTID STENT SYSTEMNIM48March 20, 2026accessdata.fda.gov
August 30, 2004P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM64October 22, 2025accessdata.fda.gov
April 30, 1997P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB131September 24, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 8, 202290840Class IIOngoingProduct/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 System XT US/CDS0701-XAn increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.accessdata.fda.gov

Compare with other makers

Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.