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Data / Medical devices / United States / Abbott Medical

Abbott Medical: FDA-registered device maker in Minnetonka, MN, United States, 20 510(k) clearances and 9 PMA approvals

Abbott Medical is registered with the FDA (registration 3013288201) in Minnetonka, MN, United States. It lists 22 device types. The FDA files 20 510(k) clearances and 9 PMA approvals under its listings, the newest dated June 30, 2022. Registered through 2027. 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
3013288201
Address
14901 Deveau Pl. Building 2, Minnetonka, MN, United States, 55345
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Complaint file establishment, Manufacturer, Manufacturer for export
First device listed
January 17, 2001
Registered through
2027
Brand names listed
410170, 410171, 410172, 410173, 410174, 410175, 410176, 410177, 410180, 410181, 410182, 410183, 410184, 410185, 410186, 410187, 410210, 410211, 410212, 410213, 410214, 410215, 410216, 410224, 410217, 410218, 410219, 410220, 410221, 410222, 410223, 410225, 410193, 410194, AVEIR AR 2 Leadless Pacemaker - Model LSP203A, AVEIR VR MINI Leadless Pacemaker- Model LSP203V, Abbott Medical Epicardial Cable, Abbott Medical Patient Cable, Abbott Medical Threshold Cable and more

Devices it lists

DeviceProduct codeClassRoleSource
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Catheter, PercutaneousDQY2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Catheter, SteerableDRA2Manufactureraccessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK3Complaint file establishmentaccessdata.fda.gov
Device, Percutaneous RetrievalMMX2Manufactureraccessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3Complaint file establishmentaccessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN3Complaint file establishmentaccessdata.fda.gov
Electrode, Pacemaker, TemporaryLDF2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Complaint file establishmentaccessdata.fda.gov
Implantable Pacemaker Pulse-GeneratorDXY3Complaint file establishmentaccessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)LWP3Complaint file establishmentaccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Manufactureraccessdata.fda.gov
Leadless PacemakerPNJ3Manufactureraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Complaint file establishment, Manufactureraccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Complaint file establishmentaccessdata.fda.gov
Permanent Pacemaker ElectrodeDTB3Complaint file establishmentaccessdata.fda.gov
Programmer, PacemakerKRG3Complaint file establishmentaccessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE3Complaint file establishmentaccessdata.fda.gov
Pulse Generator, Permanent, ImplantableNVZ3Complaint file establishmentaccessdata.fda.gov
Pulse-Generator, Single Chamber, Sensor Driven, ImplantableLWO3Complaint file establishmentaccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufactureraccessdata.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
June 30, 2022K221750CPS AIM Universal II Slittable Inner CatheterDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
April 1, 2022K213494Aveir Retrieval CatheterMMXSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
July 27, 2021K211989Aveir IntroducerDYBSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
June 3, 2020K200721Agilis HisPro Steerable Catheter With ElectrodesDQYSubstantially EquivalentAbbott (St. Jude Medical)accessdata.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
December 18, 2014K142239CPS Direct MediGuide Enabled outer catheterDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
December 18, 2014K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
March 20, 2013K130257CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETERDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
March 20, 2013K130252CPS AIM UNIVERSAL SLITTABLE INNER CATHETERDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
May 11, 2012K120296CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETERDQYSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
May 8, 2012K120298CPS EXCEL MEDIGUIDE ENABLED GUIDEWIREDQXSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
January 19, 2011K103250CPS DIRECT SL II SLITTABLE OUTER CATHETERDQYSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
August 7, 2009K092075CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005DQYSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
July 1, 2009K090613CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2DQYSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
December 12, 2008K082932CPS AIM SL SLITTABLE INNER CATHETERDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
July 14, 2006K061710CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLSDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
January 27, 1992K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDFSubstantially EquivalentDaig Corp.accessdata.fda.gov
May 7, 1991K910645DISPOSABLE PATIENT CABLEDSASubstantially EquivalentDiag Corp.accessdata.fda.gov
February 12, 1988K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODELDFSubstantially EquivalentDaig Corp.accessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
March 31, 2022P150035Aveir VR Leadless SystemPNJ42October 21, 2026accessdata.fda.gov
January 31, 2017P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP100July 21, 2026accessdata.fda.gov
June 30, 2004P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK427August 12, 2026accessdata.fda.gov
May 13, 2004P030035ANTHEM AND FRONTIER II CRT-P'SNKE202July 21, 2026accessdata.fda.gov
December 21, 2000P970013MICRONY PACEMAKERSLWO94July 21, 2026accessdata.fda.gov
January 29, 1998P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN81June 26, 2026accessdata.fda.gov
June 20, 1997P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN130October 9, 2026accessdata.fda.gov
May 10, 1996P950022TVL(TM) LEAD SYSTEMLWS145June 26, 2026accessdata.fda.gov
August 21, 1989P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY328July 21, 2026accessdata.fda.gov

Compare with other makers

Updated October 21, 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.