ANGIOSCULPT PTA SCORING BALLOON CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K072225
Device Name ANGIOSCULPT PTA SCORING BALLOON CATHETER
Applicant
ANGIOSCORE, INC.
5055 brandin court
fremont, 
CA 
94538

Applicant Contact melinda swanson
Correspondent
ANGIOSCORE, INC.
5055 brandin court
fremont, 
CA 
94538

Correspodent Contact melinda swanson
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 08/10/2007
Decision Date 10/12/2007
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