CHARGER PTA BALLON DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K112697
Device Name CHARGER PTA BALLON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC
one scimed place
maple grove, 
MN 
55311 -1566

Applicant Contact glenn jacques
Correspondent
BOSTON SCIENTIFIC
one scimed place
maple grove, 
MN 
55311 -1566

Correspodent Contact glenn jacques
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 09/16/2011
Decision Date 11/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No