Data / Medical devices / Ireland / Abbott Vascular

Abbott Vascular: FDA-registered device maker in CLONMEL Tipperary, Ireland, 3 510(k) clearances and 5 PMA approvals

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

Abbott Vascular is registered with the FDA (registration 3005718570) in CLONMEL Tipperary, Ireland. It lists 8 device types. The FDA files 3 510(k) clearances and 5 PMA approvals under its listings, the newest dated February 13, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005718570
Address: Cashel Road, CLONMEL Tipperary, Ireland, ,
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Exporter to the US, Manufacturer
First device listed: May 5, 2006
Registered through: 2026
Brand names listed: Armada 14 NC PTA Catheter, Armada 14 PTA Catheter, Armada 18 PTA Catheter, Graftmaster, Graftmaster RX, MULTI-LINK 8 Stent System, Multi-Link 8-, Multi-Link Mini Vision and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Catheter, Flow Directed	DYG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Coronary Covered Stent	NIV	f	Exporter to the US, Manufacturer	accessdata.fda.gov
Coronary Drug-Eluting Stent	NIQ	3	Exporter to the US, Manufacturer	accessdata.fda.gov
Device, Hemostasis, Vascular	MGB	3	Exporter to the US, Manufacturer	accessdata.fda.gov
Stent, Coronary	MAF	3	Exporter to the US, Manufacturer	accessdata.fda.gov
Stent, Iliac	NIO	3	Exporter to the US, 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 13, 2026	K252512	Armada 14 NC PTA Catheter	LIT	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
July 6, 2015	K151317	Armada 18 PTA Catheter	LIT	Substantially Equivalent	Abbott Vascular	accessdata.fda.gov
December 7, 2010	K102705	ARMADA 14 PTA CATHETER	LIT	Substantially Equivalent	Abbott Vascular, 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
July 31, 2012	P110043	OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM	NIO	14	January 12, 2026	accessdata.fda.gov
November 1, 2011	P110019	Xience Skypoint Everolimus Eluting Coronary Stent System	NIQ	134	October 1, 2026	accessdata.fda.gov
December 21, 2005	P050007	STARCLOSE VASCULAR CLOSURE SYSTEM	MGB	49	April 17, 2026	accessdata.fda.gov
July 16, 2003	P020047	MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS	MAF	74	June 14, 2023	accessdata.fda.gov
April 30, 1997	P960043	PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM	MGB	131	September 24, 2026	accessdata.fda.gov

Compare with other makers

Updated February 13, 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.