Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016800412

FEI Number

3016800412

Entity Name

ICS MEDICAL DEVICES LTD

City/State/Country

Galway Galway (City), IE

Establishment Address

Block 2, Ballybrit Business Park, Galway Galway (City) H91 A2WA, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ICS Medical Devices Ltd (Owner Number: 10093140)

Owner / Operator Contact Address

Block 2, Ballybrit Business Park, Galway, IE-GA H91 A2WA, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2025-04-14

Official Correspondent

John O'Malley

US Agent Details

Marybeth Gamber Email: marybeth@gamberconsultants.com Phone: (774) 2495250

Related Public Records

Same Entity

ICS Medical Devices Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

Similar Registrations

Registration Number	Establishment Name	Location
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3031311812	TORO NEUROVASCULAR, INC.	Irvine, CA, US
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3003775027	ASAHI INTECC CO., LTD.	SETO Aichi, JP
3008264254	Cerenovus, Inc.	Ciudad Juarez, Chihuahua Mexico, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016800412. Last updated year: 2026. Please use registration number 3016800412 when referencing this establishment in official correspondence.