The following data is part of a premarket notification filed by Foxhollow Technologies, Inc. with the FDA for Modification To: Silverhawk Peripheral Plaque Excision System, Models P4028/fg08300.
| Device ID | K061063 |
| 510k Number | K061063 |
| Device Name: | MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | FOXHOLLOW TECHNOLOGIES, INC. 740 BAY ROAD Redwood City, CA 94063 |
| Contact | Melissa Murphy |
| Correspondent | Melissa Murphy FOXHOLLOW TECHNOLOGIES, INC. 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 | 2006-04-17 |
| Decision Date | 2006-05-18 |
| Summary: | summary |