Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007113487

FEI Number

3007113487

Entity Name

Abbott Medical

City/State/Country

Saint Paul, MN, US

Establishment Address

177 County Road B East, Saint Paul, MN 55117, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260993

PMA Number

N/A

All Registered Proprietary Names

SJM Tailor Annuloplasty Band Amplatzer TorqVue Delivery System St. Jude Medical Mechanical Heart Valve Leaflet Tester AMPLATZER Post-Infarct Muscular VSD Occluder Amplatzer Vascular Plug (AVP) Amplatzer Vascular Plug Amplatzer TorqVue 2 Delivery Sheath Masters Series HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic) Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral) Masters Series Mechanical Heart Valve (Aortic) Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral) SJM Masters Series Mechanical Heart Valve Masters Series Mechanical Heart Valve (Mitral) Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic) SJM Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP) Regent Mechanical Heart Valve Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Aortic) Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic) Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Mitral) Regent Mechanical Heart Valve (FlexCuff) SJM Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff Epic Supra Valve (Aortic) Epic Plus Supra Valve (Aortic) Epic Plus Valve (Mitral) Epic Plus Valve (Aortic) Epic Valve (Mitral) Epic Max Valve (Aortic) Epic Valve (Aortic) Seguin Annuloplasty Ring for Mitral Valve Repair Amplatzer Guidewire AMPLATZER Vascular Plug 4 Amplatzer Cardiac Plug (ACP) Amplatzer Duct Occluder Amplatzer Duct Occluder II Amplatzer Piccolo Occluder Amplatzer TorqVue Exchange System Tendyne Retrieval System Tendyne Delivery System Tendyne Stand Components Tendyne Apical Pad Tendyne Stand Tendyne Mitral Valve Tendyne Weight Tendyne Pad Positioning System Tendyne Loading System MitraClip Clip Delivery System MitraClip G4 System MitraClip G5 Delivery system CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030 Amplatzer Guidewires AMPLATZER TorqVue 45x45 Delivery Sheath 80 cm MitraClip and TriClip Accessories Plate MitraClip and TriClip Accessories Stabilizer MitraClip and TriClip Accessories Lift Amplatzer Trevisio Intravascular Delivery System AMPLATZER Guidewires GuideRight GuideWires Amplatzer Vascular Plug II (AVP II) TriClip Steerable Guide Catheter SJM Tailor Annuloplasty Band Amplatzer TorqVue LP Delivery System Amplatzer Piccolo Delivery System AMPLATZER Sizing Balloon Attune Flexible Adjustable Annuloplasty Ring Masters Series Mechanical Heart Valve Replacement Holder/Rotators (Mitral) Rigid Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra, Trifecta valve holder handle) Mechanical Heart Valve Mitral Holder Handle (905 sizer set accessory) Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra valve holder handle) Flexible Extension Handle (Replacement) (Tailor and Seguin sizer sets) Rigid Extension Handle (Tailor, Seguin, Rigid Saddle Ring sizer sets) Mechanical Heart Valve Standard Holder Handle (905 sizer set accessory) Mechanical Heart Valve Rigid Holder Handle (905 and 907 sizer set accessory) Masters HP Series Mechanical Heart Valve Replacement Holder/Rotators (Aortic) Mechanical Heart Valve Flexible Holder Handle (905 and 907 sizer set accessory) Holder Handle (Epic Plus and Epic Max) Regent Mechanical Heart Valve Replacement Holder/Rotators (Aortic) Holder Handle (Biocor B30 series valve holder handle) Masters Series Mechanical Heart Valve Replacement Holder/Rotators (Aortic) Flexible Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra, Trifecta valve holder handle) Amplatzer Sizing Plate MitraClip G4 SCG Amplatzer Muscular VSD Occluder St. Jude Medical Mechanical Heart Valve Sizer Set Epic Plus Heart Valve Sizer Set St. Jude Medical Mechanical Heart Valve Individual Sizer (905 sizer set accessory) SJM Tailor Annuloplasty Ring Sizer Set Epic Heart Valve Sizer Set St Jude Medical Bioprosthetic Heart Valve Sizer Set (Biocor, Biocor Supra, Epic, Epic Supra valve sizer set) Regent Mechanical Heart Valve Sizer Set Rigid Saddle Ring Sizer Set Seguin Annuloplasty Ring Sizer Set Double-ended Handle Sizer Rings (15mm MHV Sizer) Mechanical Heart Valve Standard Sizer Ring (905 sizer set accessory) Epic Max Heart Valve Sizer Set Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Bioprosthetic Heart Valve Rigid Saddle Ring SJM Rigid Saddle Ring Amplatzer TorqVue LP Catheter Tendyne Transcatheter Mitral Valve System Amplatzer TorqVue Delivery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2015-09-11
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2015-09-11
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-10-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1996-05-14
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-09-27
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2016-10-31
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
NGV	System, Appendage Closure, Left Atrial	Unknown	Class 3	N/A	2021-08-14
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2007-10-16
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2007-10-16
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2007-10-16
DYE	Replacement Heart-Valve	Cardiovascular	Class 3	870.3925	2007-10-16
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2009-12-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-12-01
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered	Unknown	Class 3	N/A	2025-05-27
NKM	Mitral Valve Repair Devices	Unknown	Class 3	N/A	2013-11-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-11-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Cardiovascular	Class 1	870.3955	2024-11-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-06-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-07-20
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-08-29
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-10-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	Class 3	N/A	2013-02-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-12-18
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2017-02-17
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2013-08-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-04-11
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3935	1996-05-14
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2017-02-17
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2024-02-05
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2017-02-17
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	1996-05-14
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2011-04-21
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2011-04-21
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-10-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DYE	Replacement Heart-Valve	Cardiovascular	Class 3	870.3925	2019-04-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2020-05-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K253232	ABBOTT MEDICAL	Seguin Annuloplasty Ring	2025-10-29
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0491-2025	Abbott Medical	3	Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025	Abbott Medical	3	Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025	Abbott Medical	3	Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Z-0494-2025	Abbott Medical	3	Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Z-0495-2025	Abbott Medical	3	Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Similar Registrations

Registration Number	Establishment Name	Location
3014918977	Abbott Medical Costa Rica Limitada (Structural Heart)	El Coyol Alajuela, CR
3026560514	PFM MEDICAL MSG GMBH	Nonnweiler Saarland, DE
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US
3012179728	St. Jude Medical	Roseville, MN, US
2135147	Abbott Medical	Plymouth, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007113487. Last updated year: 2026. Please use registration number 3007113487 when referencing this establishment in official correspondence.