510(k) K171146 ยท DQY Catheter, Percutaneous
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
| Applicant | Arrow International, Inc. (Subsidiary of Telelflex Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Jun 23, 2017 |
| Received | Apr 19, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6
RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP
ACCESS TRAY/ASK-04001-MS
RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1
VESSEL CATH KIT: 20GA X 5 Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.