510(k) K810962 ยท DQY Catheter, Percutaneous
ARROW VESSEL CATHETER. KIT W/20GA INDWEL
| Applicant | Arrow Intl., Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 29, 1981 |
| Received | Apr 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810962
| 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 Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418 Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.