510(k) K111388 ยท MCW Catheter, Peripheral, Atherectomy
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
| Applicant | Cardiovascular Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Jul 26, 2011 |
| Received | May 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111388
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.