Data / Medical devices / Ireland / Vetex Medical Limited
Vetex Medical Limited: FDA-registered device maker in Ballinasloe Galway(County), Ireland, 1 510(k) clearance
Vetex Medical Limited is registered with the FDA (registration 3014787927) in Ballinasloe Galway(County), Ireland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014787927
- Address
- Surmodics IDA Business Park, Ballinasloe Galway(County), Ireland, H53 K8P4
- Owner or operator
- Vetex Medical Limited (10085653)
- Roles
- Specification developer
- First device listed
- July 27, 2022
- Registered through
- 2026
- Brand names listed
- Pounce Venous Thrombectomy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Specification developer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 22, 2020 | K201705 | ReVene Thrombectomy Catheter | QEW | Substantially Equivalent | Vetex Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Continuous Flush
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
Updated December 22, 2020. 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.