510(k) K043401 ยท DRB Stylet, Catheter
SPECTRANETICS LLD CS, MODEL 518-039
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Mar 16, 2005 |
| Received | Dec 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043401
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.