510(k) K242281 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
| Applicant | Arrow International, LLC (A subsidiary of Teleflex, Inc.), Morrisville NC, US |
| Decision | Substantially Equivalent, Dec 20, 2024 |
| Received | Aug 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242281
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.