510(k) K072748 ยท MCW Catheter, Peripheral, Atherectomy
MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
| Applicant | Cardiovascular Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 9, 2007 |
| Received | Sep 27, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072748
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.