510(k) K021120 ยท DQY Catheter, Percutaneous
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, May 2, 2002 |
| Received | Apr 8, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021120
| 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 |
| Apr 11, 2018 | Arrow International Inc Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.