510(k) K954604 ยท MCW Catheter, Peripheral, Atherectomy
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY
| Applicant | Heart Technology Mfg., Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jan 18, 1996 |
| Received | Oct 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954604
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.