DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K071350
Device Name DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
Applicant
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr.
st. paul, 
MN 
55112

Applicant Contact michael j kallok
Correspondent
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr.
st. paul, 
MN 
55112

Correspodent Contact michael j kallok
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 05/14/2007
Decision Date 08/22/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No