510(k) K073434 ยท DYB Introducer, Catheter
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
| Applicant | Bipore, Inc., Northvale NJ, US |
| Decision | Substantially Equivalent, Apr 1, 2008 |
| Received | Dec 6, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073434
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.