510(k) K151513 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow Endurance Extended Dwell Peripheral Catheter System
| Applicant | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Jul 8, 2015 |
| Received | Jun 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2018 | Arrow International Inc ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.