510(k) K081944 ยท MCW Catheter, Peripheral, Atherectomy
MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
| Applicant | Cardio Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Aug 14, 2008 |
| Received | Jul 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081944
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.