510(k) K163513 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow Endurance Extended Dwell Peripheral Catheter System
| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Feb 24, 2017 |
| Received | Dec 15, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2023 | ARROW INTERNATIONAL Inc. ARROW Endurance Extended Dwell Peripheral Catheter System Open, Classified |
FOZ | None listed |
| Dec 6, 2019 | Arrow International Inc Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.