510(k) K912050 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
NOVOSTE VESSEL DILATER
| Applicant | Novaste Corp., Aguadilla PR, US |
| Decision | Substantially Equivalent, Oct 9, 1991 |
| Received | May 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912050
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.