Data / Medical devices / Ireland / Filtertek, B.V. (an Itw Medical Company)
Filtertek, B.V. (an Itw Medical Company): FDA-registered device maker in Newcastle West Limerick(County), Ireland, 1 510(k) clearance
Filtertek, B.V. (an Itw Medical Company) is registered with the FDA (registration 3004068971) in Newcastle West Limerick(County), Ireland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 22, 2015. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004068971
- Address
- Industrial Estate, Newcastle West Limerick(County), Ireland, none
- Owner or operator
- Filtertek, B.V. (An ITW Medical Company) (10051079)
- Roles
- Manufacturer
- First device listed
- January 15, 2018
- Registered through
- 2026
- Brand names listed
- ITW-Filtertek
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | 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 |
|---|---|---|---|---|---|---|
| October 22, 2015 | K150902 | 330psi Extension Y-Line with Dual Check Valve | DXT | Substantially Equivalent | Coeur, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 22, 2015. 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.