DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K071427
Device Name DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Applicant
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr.
st. paul, 
MN 
55112

Applicant Contact cindy setum
Correspondent
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr.
st. paul, 
MN 
55112

Correspodent Contact cindy setum
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 05/23/2007
Decision Date 08/30/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls