510(k) K964814 ยท DYB Introducer, Catheter
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
| Applicant | Bipore, Inc., Northvale NJ, US |
| Decision | Substantially Equivalent, May 7, 1997 |
| Received | Nov 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964814
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.