510(k) K213855 ยท PND Midline Catheter
Arrow Pressure Injectable Midline Catheter
| Applicant | Arrow International, LLC Subsidiary of Teleflex Incorporated, Morrisville NC, US |
| Decision | Substantially Equivalent, Sep 2, 2022 |
| Received | Dec 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC Open, Classified |
PND | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.