MUSTANG BALLOON DILATATION CATHETERS


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K103751
Device Name MUSTANG BALLOON DILATATION 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 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 12/23/2010
Decision Date 03/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No