MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM


Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K072748
Device Name MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
Applicant
CARDIOVASCULAR SYSTEMS, INC.
18555 37th ave n
plymouth, 
MN 
55446

Applicant Contact john carline
Correspondent
CARDIOVASCULAR SYSTEMS, INC.
18555 37th ave n
plymouth, 
MN 
55446

Correspodent Contact john carline
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 09/27/2007
Decision Date 11/09/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No