510(k) K123445 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
NMI COAXIAL MICROINTRODUCER SET
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Apr 1, 2013 |
| Received | Nov 8, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123445
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.