510(k) K061063 ยท MCW Catheter, Peripheral, Atherectomy
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
| Applicant | Foxhollow Technologies, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, May 18, 2006 |
| Received | Apr 17, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061063
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.