BRIVANT, LTD.

FDA Device Registration & Listing · GALWAY, IE · Registration 3006010712

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006010712
FEI Number
3006010712
Entity Name
BRIVANT, LTD.
City/State/Country
GALWAY, IE
Establishment Address
PARKMORE WEST BUSINESS PARK, GALWAY --, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Lake Region Medical (Owner Number: 9083703)
Owner / Operator Contact Address
Parkmore West Business Park, Galway, IE-G H91CK22, IE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K102211
PMA Number
N/A

All Registered Proprietary Names

Enroute Transcarotid 014'' Guidewire

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-10-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2009-11-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-09-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2006-08-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-12-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-04-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2010-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

Charlene Grilletto Business: Lake Region Medical Email: charlene.grilletto@integer.net Phone: (215) 5342280

Related Public Records

Same Entity

Lake Region Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004063494 Lake Region Medical TRENTON, GA, US
9680001 Venusa de Mexico S. de R.L de C.V CIUDAD JUAREZ Chihuahua, MX
9681477 LAKE REGION MEDICAL LIMITED NEW ROSS Wexford, IE
2126666 Lake Region Medical CHASKA, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

Registration Number Establishment Name Location
3024743081 EMBRACE MEDICAL LTD. Tel Aviv, IL
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3018070217 SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD. Suzhou Jiangsu, CN
3015522130 NANO4IMAGING USA, LLC. Dublin, OH, US
3007635982 Confluent Medical Technologies, Inc Fremont, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006010712. Last updated year: 2026. Please use registration number 3006010712 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.