510(k) K122987 ยท MCW Catheter, Peripheral, Atherectomy
STEALTH 360 ORBITAL PAD SYSTEM
| Applicant | Cardiovascular Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Oct 25, 2012 |
| Received | Sep 26, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122987
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.