ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039


Device Classification Name

catheter, percutaneous

510(k) Number K080151
Device Name ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
Applicant
ANGIOSCORE, INC.
5055 brandin court
fremont, 
CA 
94538

Applicant Contact karin j gastineau
Correspondent
ANGIOSCORE, INC.
5055 brandin court
fremont, 
CA 
94538

Correspodent Contact karin j gastineau
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 01/22/2008
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls