510(k) K061188 ยท MCW Catheter, Peripheral, Atherectomy
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
| Applicant | Foxhollow Technologies, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Oct 23, 2006 |
| Received | Apr 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2010 | Ev3, Inc. SilverHawk Peripheral Cutter Driver Plaque Excision System
REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.