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Abbott Medical: FDA-registered device maker in Westfield, IN, United States, 2 510(k) clearances and 1 PMA approval

Name: Abbott Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Abbott Medical is registered with the FDA (registration 3020950818) in Westfield, IN, United States. It lists 3 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated December 31, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3020950818
Address: 1820 Bastian Court, Westfield, IN, United States, 46074
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer, Manufacturer for export
First device listed: May 18, 2012
Registered through: 2026
Brand names listed: CPS Direct PL, CPS Direct PL VBT, MitraClip Clip Delivery System, MitraClip G4 Clip Delivery System, MitraClip G4 Steerable Guide Catheter, MitraClip G4 System, MitraClip NTR Clip Delivery System, MitraClip Steerable Guide Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Catheter, Steerable	DRA	2	Manufacturer	accessdata.fda.gov
Mitral Valve Repair Devices	NKM	3	Manufacturer, Manufacturer for export	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 31, 2024	K243224	MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)	DQY	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
May 29, 2019	K190167	MitraClip G4 Steerable Guide Catheter	DRA	Substantially Equivalent	Abbott	accessdata.fda.gov

PMA approvals

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

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
October 24, 2013	P100009	MITRACLIP DELIVERY SYSTEM	NKM	82	June 25, 2026	accessdata.fda.gov

Compare with other makers

Updated June 25, 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.