510(k) K043465 ยท PDU Catheter For Crossing Total Occlusions
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Aug 18, 2005 |
| Received | Dec 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043465
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.