510(k) K080604 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PRESSURE INJFECTABLE PICC
| Applicant | Arrow International, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Jun 27, 2008 |
| Received | Mar 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2018 | Arrow International Inc ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.