STEALTH 360 ORBITAL PAD SYSTEM


Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K110389
Device Name STEALTH 360 ORBITAL PAD SYSTEM
Applicant
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr
saint paul, 
MN 
55112

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

Correspodent Contact megan m brandt
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 02/10/2011
Decision Date 03/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls