SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE

Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K071432
Device Name SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
Applicant
FOX HOLLOW TECHNOLOGIES
740 bay road
redwood city, 
CA 
94063

Applicant Contact melissa s murphy
Correspondent
FOX HOLLOW TECHNOLOGIES
740 bay road
redwood city, 
CA 
94063

Correspodent Contact melissa s murphy
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 05/23/2007
Decision Date 02/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No