510(k) K092378 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
SPECTRANETICS VISISHEATH DILATOR SHEATH
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Nov 2, 2009 |
| Received | Aug 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092378
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.