DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM


Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K111388
Device Name DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
Applicant
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr.
st. paul, 
MN 
55112

Applicant Contact megan m brandt
Correspondent
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr.
st. paul, 
MN 
55112

Correspodent Contact megan m brandt
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 05/17/2011
Decision Date 07/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No