Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2135147

FEI Number

3005334138

Entity Name

Abbott Medical

City/State/Country

Plymouth, MN, US

Establishment Address

5050 NATHAN LANE NORTH, Plymouth, MN 55442, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

N/A

PMA Number

P100029

All Registered Proprietary Names

SJM Tailor Annuloplasty Band AMPLATZER Vascular Plug 4 Seguin Annuloplasty Ring for Mitral Valve Repair 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 TorqVue LP Catheter 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) Amplatzer Vascular Plug (AVP) Amplatzer Vascular Plug Amplatzer Sizing Plate Amplatzer Piccolo Delivery System Rigid Saddle Ring SJM Rigid Saddle Ring St. Jude Medical Mechanical Heart Valve Leaflet Tester 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 Amplatzer Cardiac Plug Amplatzer Amulet Left Atrial Appendage Occluder Amulet Steerable Delivery Sheath Amulet Steerable Delivery Sheath Amplatzer Guidewire Amplatzer Muscular VSD Occluder TriClip G4 System TriClip G4 Delivery System TriClip G5 Delivery system Attune Flexible Adjustable Annuloplasty Ring AMPLATZER Vascular Plug - II ES Steerable Guide Catheter Navitor Loading System FlexNav Delivery System FlexNav Loading System Navitor Transcatheter Aortic Valve Navitor Titan Transcatheter Aortic Valve Navitor Loading System - LG+ Portico Transcatheter Aortic Valve Amplatzer Vascular Plug II (AVP II) Amplatzer TorqVue 2 Delivery Sheath Amplatzer Guidewires MitraClip G5 Steerable Guide Catheter CPS Direct PL CPS Direct PL VBT Renal Guide Catheter MitraClip Steerable Guide Catheter TriClip G5 Steerable Guide Catheter MitraClip G4 Steerable Guide Catheter TriClip Steerable Guide Catheter Amplatzer TorqVue LP Delivery System MitraClip and TriClip Accessories Plate MitraClip and TriClip Accessories Stabilizer MitraClip and TriClip Accessories Lift Amplatzer TorqVue Delivery System Amplatzer Trevisio Intravascular Delivery System SJM Tailor Annuloplasty Band 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 AMPLATZER Guidewires GuideRight GuideWires 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 Amplatzer Cardiac Plug (ACP) Amplatzer Duct Occluder Amplatzer Duct Occluder II Amplatzer Piccolo Occluder Amplatzer TorqVue Exchange System TriClip G5 Steerable Guide Catheter MitraClip G5 Steerable Guide Catheter AMPLATZER TorqVue 45x45 Delivery Sheath 80 cm Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Bioprosthetic Heart Valve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-10-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2009-12-22
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3935	1996-05-14
NGV	System, Appendage Closure, Left Atrial	Unknown	Class 3	N/A	2021-08-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
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
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-12-18
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
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1996-05-14
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	1996-05-14
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2007-12-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-04-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-09-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-12-01
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2017-02-17
NPS	Tricuspid Valve Repair Device, Percutaneously Delivered	Unknown	Class 3	N/A	2024-04-02
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2013-08-01
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2019-07-17
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	Class 3	N/A	2021-09-17
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-04-11
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2016-10-31
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-05-18
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
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-06-12
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-10-16
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered	Unknown	Class 3	N/A	2025-05-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-07-20
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2007-10-16
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
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

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
K813276	Shiley, Inc.	IONESCU-SHILEY VALVE HOLDER & HANDLE	1981-12-10
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

Similar Registrations

Registration Number	Establishment Name	Location
2025587	Medtronic Heart Valves Division	Santa Ana, CA, US
3007113487	Abbott Medical	Saint Paul, MN, US
2029275	Sterigenics U.S., LLC	Corona, CA, US
1720929	ISOMEDIX OPERATIONS INC.	Sandy, UT, US
9617601	Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2135147. Last updated year: 2026. Please use registration number 2135147 when referencing this establishment in official correspondence.