510(k) K053460 ยท MCW Catheter, Peripheral, Atherectomy
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
| Applicant | Fox Hollow Technologies, Redwood City CA, US |
| Decision | Substantially Equivalent, Jan 13, 2006 |
| Received | Dec 13, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053460
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.