510(k) K041630 ยท MCW Catheter, Peripheral, Atherectomy
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
| Applicant | Cardiovascular Systems Incorporated, Stoughton WI, US |
| Decision | Substantially Equivalent, Jan 31, 2005 |
| Received | Jun 16, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K041630
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.