Data / Medical devices / United States / Abbott Medical

Abbott Medical: FDA-registered device maker in Caguas, PR, United States, 5 510(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 2648612) in Caguas, PR, United States. It lists 4 device types. The FDA files 5 510(k) clearances and 1 PMA approval under its listings, the newest dated February 24, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2648612
Address: LOT 20 B Street Caguas West Industrial Park, Caguas, PR, United States, 00725
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer, Manufacturer for export
First device listed: October 16, 2007
Registered through: 2026
Brand names listed: FemoStop Gold, FemoStop II Plus, Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ), Masters Series HP Valved Graft with Gelweave Valsalva Technology (VAVGJ), Masters Series Mechanical Heart Valve (Aortic), Masters Series Mechanical Heart Valve (Mitral), Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic), Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic) and more

Devices it lists

Device	Product code	Class	Role	Source
Clamp, Vascular	DXC	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Heart-Valve, Mechanical	LWQ	3	Manufacturer	accessdata.fda.gov
Ring, Annuloplasty	KRH	2	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	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
February 24, 2011	K110193	FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F	DXC	Substantially Equivalent	St. Jude Medical Systems AB	accessdata.fda.gov
August 27, 2009	K092310	SEGUIN ANNULOPLASTY RING	KRH	Substantially Equivalent	St Jude Medical	accessdata.fda.gov
December 17, 2004	K042734	SJM RIGID SADDLE RING MODEL RSAR-(SIZE)	KRH	Substantially Equivalent	St. Jude Medical, Inc.	accessdata.fda.gov
September 19, 2002	K022363	SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)	KRH	Substantially Equivalent	St. Jude Medical, Inc.	accessdata.fda.gov
January 15, 2002	K014161	SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)	KRH	Substantially Equivalent	St. Jude Medical, Inc.	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
December 17, 1982	P810002	BILEAFLET-CENTER OPENING CARDIAC VALVE	LWQ	119	June 11, 2026	accessdata.fda.gov

Compare with other makers

Updated June 11, 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.