510(k) K953997 ยท MCW Catheter, Peripheral, Atherectomy
ROTABLATOR ROTATIONAL ANGIOPLASTY
| Applicant | Heart Technology Mfg., Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Dec 22, 1995 |
| Received | Aug 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953997
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.