510(k) K094036 ยท MCW Catheter, Peripheral, Atherectomy
TURBO-TANDEM SYSTEM MODEL 472-110
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jan 25, 2010 |
| Received | Dec 30, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K094036
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.