MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K081220
Device Name MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
Applicant
ANGIOSCORE, INC.
5055 brandin court
fremont, 
CA 
94538

Applicant Contact kimberley kline
Correspondent
ANGIOSCORE, INC.
5055 brandin court
fremont, 
CA 
94538

Correspodent Contact kimberley kline
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received 04/30/2008
Decision Date 05/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No