SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
FDA 510(k) clearance K061188 · decided 2006-10-23
Clearance details
- K-number
- K061188
- Device name
- SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- Applicant
- Foxhollow Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-28
- Decision date
- 2006-10-23
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Steri recall (Z-1162-2010) | Ev3, Inc. | 2010-03-18 |