510(k) K152913 ยท DYB Introducer, Catheter
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
| Applicant | Creganna Medical Aslo Business AS Cregganna Tactx Medical, Galway, IE |
| Decision | Substantially Equivalent, Jul 21, 2016 |
| Received | Oct 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152913
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2023 | Creganna Medical Devices Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.