The following data is part of a premarket notification filed by Fox Hollow Technologies with the FDA for Modification To Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300,.
| Device ID | K053460 |
| 510k Number | K053460 |
| Device Name: | MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | FOX HOLLOW TECHNOLOGIES 740 BAY ROAD Redwood City, CA 94063 |
| Contact | Melissa Murphy |
| Correspondent | Melissa Murphy FOX HOLLOW TECHNOLOGIES 740 BAY ROAD 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 | 2005-12-13 |
| Decision Date | 2006-01-13 |
| Summary: | summary |