510(k) K131092 ยท MCW Catheter, Peripheral, Atherectomy
STEALTH 360 ORBITAL PAD SYSTEM
| Applicant | Cardio Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Jun 24, 2013 |
| Received | Apr 18, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131092
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.