510(k) K960379 ยท MCW Catheter, Peripheral, Atherectomy
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
| Applicant | Heart Technology Mfg., Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Apr 25, 1996 |
| Received | Jan 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960379
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.