Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004068971

FEI Number

3004068971

Entity Name

FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)

City/State/Country

Newcastle West Limerick, IE

Establishment Address

Industrial Estate, Newcastle West Limerick none, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Filtertek, B.V. (An ITW Medical Company) (Owner Number: 10051079)

Owner / Operator Contact Address

Industrial Estate, Newcastle West, IE-LK V42 WD54, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150902

PMA Number

N/A

All Registered Proprietary Names

ITW-Filtertek

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2018-01-15

Official Correspondent

Neil Spillane

US Agent Details

David Thompson Business: Drake Thompson Email: dthompson@itwmedical.com Phone: (252) 4025078

Related Public Records

Same Entity

Filtertek, B.V. (An ITW Medical Company)

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-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004068971. Last updated year: 2026. Please use registration number 3004068971 when referencing this establishment in official correspondence.