MUSTANG BALLOON DILATAION CATHETERS


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K110122
Device Name MUSTANG BALLOON DILATAION CATHETERS
Applicant
BOSTON SCIENTIFIC
one scimed place
maple grove, 
MN 
55311 -1566

Applicant Contact anne v rossi
Correspondent
BOSTON SCIENTIFIC
one scimed place
maple grove, 
MN 
55311 -1566

Correspodent Contact anne v rossi
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 01/18/2011
Decision Date 05/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No