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Data / Medical devices / United States / Abbott Medical

Abbott Medical: FDA-registered device maker in Saint Paul, MN, United States, 32 510(k) clearances and 12 PMA approvals

Abbott Medical is registered with the FDA (registration 3007113487) in Saint Paul, MN, United States. It lists 21 device types. The FDA files 32 510(k) clearances and 12 PMA approvals under its listings, the newest dated July 2, 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 Medical
FDA registration number
3007113487
Address
177 County Road B East, Saint Paul, MN, United States, 55117
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Manufacturer, Manufacturer for export, Specification developer
First device listed
May 14, 1996
Registered through
2026
Brand names listed
AMPLATZER Guidewires, AMPLATZER Post-Infarct Muscular VSD Occluder, AMPLATZER Sizing Balloon, AMPLATZER Vascular Plug - II ES, AMPLATZER Vascular Plug 4, Amplatzer Guidewire, Amplatzer Piccolo™ Delivery System, Amplatzer Piccolo™ Occluder and more

Devices it lists

DeviceProduct codeClassRoleSource
Aortic Valve, Prosthesis, Percutaneously DeliveredNPT3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Cardiovascular Delivery Catheter System Positioning And Stabilization DeviceQWA1Specification developeraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Specification developeraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, SteerableDRA2Specification developeraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Manufacturer for export, Specification developeraccessdata.fda.gov
Heart-Valve, MechanicalLWQ3Manufacturer, Specification developeraccessdata.fda.gov
Heart-Valve, Non-Allograft TissueLWR3Manufacturer, Specification developeraccessdata.fda.gov
Holder, Heart-Valve, ProsthesisDTJ1Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufactureraccessdata.fda.gov
Mitral Valve Repair DevicesNKM3Specification developeraccessdata.fda.gov
Occluder, Patent Ductus, ArteriosusMAE3Specification developeraccessdata.fda.gov
Prosthesis, Mitral Valve, Percutaneously DeliveredNPU3Manufactureraccessdata.fda.gov
Replacement Heart-ValveDYE3Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Ring, AnnuloplastyKRH2Manufactureraccessdata.fda.gov
Sizer, Heart-Valve, ProsthesisDTI1Specification developeraccessdata.fda.gov
System, Appendage Closure, Left AtrialNGV3Specification developeraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Specification developeraccessdata.fda.gov
Transcatheter Septal OccluderMLV3Specification developeraccessdata.fda.gov
Tricuspid Valve Repair Device, Percutaneously DeliveredNPS3Specification developeraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufacturer, Specification 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
July 2, 2026K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQYSubstantially EquivalentAbbottaccessdata.fda.gov
June 17, 2026K261631Amplatzer TorqVue Exchange SystemDQYSubstantially EquivalentAbbott Medicalaccessdata.fda.gov
April 24, 2026K260993Amplatzer TorqVue Delivery SystemDQYSubstantially EquivalentAbbottaccessdata.fda.gov
March 13, 2026K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 17, 2025K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)DQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
October 3, 2025K250031Amplatzer GuidewireDQXSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
April 25, 2025K250426Amulet™ Steerable Delivery SheathDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 31, 2024K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 26, 2024K241538TriClip Steerable Guide CatheterDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
September 29, 2023K232690Amulet™ Steerable Delivery SheathDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
September 28, 2022K221397MitraClip G4 Steerable Guide CatheterDRASubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
September 27, 2021K212738Amplatzer Talisman Delivery SheathDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
May 29, 2019K190167MitraClip G4 Steerable Guide CatheterDRASubstantially EquivalentAbbottaccessdata.fda.gov
April 5, 2019K190581Amplatzer Trevisio Intravascular Delivery SystemDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 23, 2016K163000AMPLATZER TorqVue 45x45 Delivery SheathDQYSubstantially EquivalentAga Medical COrporation (Wholly Owned by St. Jude Medical COaccessdata.fda.gov
September 9, 2016K162228TorqVue Low Profile Delivery CatheterDQYSubstantially EquivalentAga Medical Corporation (Wholly Owned by St.Jude Medical Coraccessdata.fda.gov
August 15, 2013K131063AMPLATZER TORQ VUE LP DELIVERY SYSTEMDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
June 12, 2012K113658AMPLATZER VASCULAR PLUG 4KRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
February 5, 2010K093476AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120DQYSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
October 16, 2009K092876SJM ATTUNE ANNULOPLASTY RINGKRHSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
August 27, 2009K092310SEGUIN ANNULOPLASTY RINGKRHSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
May 16, 2008K080994AMPLATZER TORQVUE EXCHANGE SYSTEMDQYSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
November 2, 2007K072313AMPLATZER TORQVUE DELIVERY SYSTEMDQYSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
August 15, 2007K071699AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022KRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
June 18, 2007K071125AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016KRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
April 27, 2006K053187AMPLATZER NOODLEWIRE GUIDEWIREDQXSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
December 30, 2005K053440AMPLATZER SIZING BALLOON IIMJNSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
December 17, 2004K042734SJM RIGID SADDLE RING MODEL RSAR-(SIZE)KRHSubstantially EquivalentSt. Jude Medical, Inc.accessdata.fda.gov
September 9, 2003K031810AMPLATZER VASCULAR PLUGKRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
September 19, 2002K022363SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)KRHSubstantially EquivalentSt. Jude Medical, Inc.accessdata.fda.gov
January 15, 2002K014161SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)KRHSubstantially EquivalentSt. Jude Medical, Inc.accessdata.fda.gov
March 31, 1994K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQXSubstantially EquivalentLake Region Mfg., Inc.accessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
May 23, 2025P240042Tendyne Transcatheter Mitral Valve SystemNPU4August 31, 2026accessdata.fda.gov
April 1, 2024P230007TriClip G4 SystemNPS22June 25, 2026accessdata.fda.gov
September 17, 2021P190023Portico Transcatheter Aortic Valve Implantation SystemNPT32July 9, 2026accessdata.fda.gov
August 14, 2021P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV19August 28, 2026accessdata.fda.gov
October 28, 2016P120021AMPLATZER PFO OCCLUDERMLV26May 28, 2026accessdata.fda.gov
October 24, 2013P100009MITRACLIP DELIVERY SYSTEMNKM82June 25, 2026accessdata.fda.gov
April 20, 2011P100029ST JUDE MEDICAL TRIFECTA VALVELWR46December 14, 2022accessdata.fda.gov
September 7, 2007P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV47May 28, 2026accessdata.fda.gov
August 5, 2005P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR60September 18, 2026accessdata.fda.gov
May 14, 2003P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE65May 28, 2026accessdata.fda.gov
December 5, 2001P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV76May 28, 2026accessdata.fda.gov
December 17, 1982P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ119June 11, 2026accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
October 17, 202495627Class IIOngoingAbbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.accessdata.fda.gov

Compare with other makers

Updated August 31, 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.