510(k) K945586 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
FLEXIBLE DILATING SHEATH
| Applicant | Med Institute, Inc., West Lafayette IN, US |
| Decision | Substantially Equivalent, Apr 4, 1997 |
| Received | Nov 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945586
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.