Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020950818

FEI Number

3020950818

Entity Name

Abbott Medical

City/State/Country

Westfield, IN, US

Establishment Address

1820 Bastian Court, Westfield, IN 46074, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

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

N/A

All Registered Proprietary Names

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 Steerable Guide Catheter MitraClip NTR Clip Delivery System MitraClip G4 Clip Delivery System MitraClip XTR Clip Delivery System MitraClip G5 Delivery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-05-18
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2019-07-17
NKM	Mitral Valve Repair Devices	Unknown	Class 3	N/A	2020-03-24

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
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
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-0459-2026	Abbott Medical	3	Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
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

Similar Registrations

Registration Number	Establishment Name	Location
3039062605	CORVITEX CORPORATION	Raleigh, NC, US
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
3010370269	STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD	Cape Town Western Cape, ZA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020950818. Last updated year: 2026. Please use registration number 3020950818 when referencing this establishment in official correspondence.