510(k) K000313 ยท DYB Introducer, Catheter
TEARAWAY INTRODUCER SHEATH
| Applicant | Xentek Medical, Inc., Athens TX, US |
| Decision | Substantially Equivalent, Jun 16, 2000 |
| Received | Feb 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.