CHARGER BALLOON DILATATION CATHETER


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K112701
Device Name CHARGER BALLOON 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 876.5010
Classification Product Code
FGE  
Date Received 09/16/2011
Decision Date 10/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No