510(k) K021723 ยท DYB Introducer, Catheter
SHEATH ADAPTER, MODEL SA-09847
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Aug 8, 2002 |
| Received | May 24, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2018 | Arrow International Inc Sheath Adapter with Cath-Gard Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.