The following data is part of a premarket notification filed by Fox Hollow Technologies with the FDA for Silverhawk-r Peripheral Plaque Excision System For Surgical Use.
| Device ID | K071432 |
| 510k Number | K071432 |
| Device Name: | SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | FOX HOLLOW TECHNOLOGIES 740 BAY ROAD Redwood City, CA 94063 |
| Contact | Melissa S Murphy |
| Correspondent | Melissa S Murphy FOX HOLLOW TECHNOLOGIES 740 BAY ROAD Redwood City, CA 94063 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-23 |
| Decision Date | 2008-02-12 |
| Summary: | summary |