510(k) K043553 ยท MCW Catheter, Peripheral, Atherectomy
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
| Applicant | Fox Hollow Technologies, Redwood City CA, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Dec 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043553
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.