510(k) K024243 ยท MCW Catheter, Peripheral, Atherectomy
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
| Applicant | Fox Hollow Technologies, Redwood City CA, US |
| Decision | Substantially Equivalent, Jun 20, 2003 |
| Received | Dec 23, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Fox Hollow Technologies ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015;
Manufactured by: FoxHollow Technologies, Redwood City, CA 94063 Terminated |
--- | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.