510(k) K970296 ยท MCW Catheter, Peripheral, Atherectomy
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
| Applicant | Boston Scientific Corp, Redmond WA, US |
| Decision | Substantially Equivalent, Aug 29, 1997 |
| Received | Jan 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970296
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.