Data / Medical devices / Ireland / Brivant, Ltd.

Brivant, Ltd.: FDA-registered device maker in GALWAY Galway(County), Ireland, 11 510(k) clearances

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

Brivant, Ltd. is registered with the FDA (registration 3006010712) in GALWAY Galway(County), Ireland. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 19, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006010712
Address: Parkmore West Business Park, GALWAY Galway(County), Ireland, --
Owner or operator: Lake Region Medical (9083703)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: August 15, 2006
Registered through: 2026
Brand names listed: Enroute Transcarotid 014'' Guidewire

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous, Neurovasculature	QJP	2	Contract manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Complaint file establishment, Contract manufacturer, 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
March 19, 2026	K253746	Enroute 0.014'' Transcarotid Guidewire	DQX	Substantially Equivalent	Lake Region Medical	accessdata.fda.gov
October 18, 2016	K160643	ENROUTE 0.014 Guidewire	DQX	Substantially Equivalent	Lake Region Medical	accessdata.fda.gov
December 17, 2014	K140536	HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE	DQX	Substantially Equivalent	Lake Region Medical	accessdata.fda.gov
September 4, 2014	K141831	HYDRAVIEW GUIDEWIRE	DQX	Substantially Equivalent	Brivant Limited	accessdata.fda.gov
October 17, 2012	K122856	CHARTER GUIDEWIRE	DQX	Substantially Equivalent	Brivant, Ltd.	accessdata.fda.gov
February 14, 2012	K120137	VICTORY GUIDEWIRE (32 MODELS)	DQX	Substantially Equivalent	Brivant, Ltd.	accessdata.fda.gov
September 3, 2010	K102211	CRUISER 18 GUIDEWIRE	DQX	Substantially Equivalent	Brivant, Ltd.	accessdata.fda.gov
July 7, 2009	K083094	STREAMER POLYMER GUIDEWIRE	DQX	Substantially Equivalent	Brivant, Ltd.	accessdata.fda.gov
December 4, 2008	K082935	VISION WIRE CORONARY GUIDEWIRE	DQX	Substantially Equivalent	Biotronik, Inc.	accessdata.fda.gov
January 9, 2008	K073082	CPS COURIER GUIDEWIRE	DQX	Substantially Equivalent	Brivant, Ltd.	accessdata.fda.gov
June 7, 2006	K060551	BRIVANT GUIDEWIRE	DQX	Substantially Equivalent	Brivant Limited	accessdata.fda.gov

Compare with other makers

Updated March 19, 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.