510(k) K781978 ยท FMF Syringe, Piston
PUNCTURE KIT, DISPOSALBE VEIN
| Applicant | Arrow Intl., Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 12, 1978 |
| Received | Nov 27, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
CVC KIT: 16 GA X 8IN/AK-04210,
CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300,
CVC KIT: 14 GA X 6 IN/CK-04711 Open, Classified |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.