510(k) K051513 ยท DYB Introducer, Catheter
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
| Applicant | Bipore, Inc., Northvale NJ, US |
| Decision | Substantially Equivalent, Dec 7, 2005 |
| Received | Jun 2, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K051513
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.