The following data is part of a premarket notification filed by Fox Hollow Technologies with the FDA for Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300.
| Device ID | K043553 |
| 510k Number | K043553 |
| Device Name: | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | FOX HOLLOW TECHNOLOGIES 300 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Melissa Murphy |
| Correspondent | Melissa Murphy FOX HOLLOW TECHNOLOGIES 300 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-02-18 |
| Summary: | summary |