510(k) K112032 ยท DQY Catheter, Percutaneous
8FR TURBO - TANDEM SYSTEM
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Oct 17, 2011 |
| Received | Jul 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112032
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.