BLUE MAX BALLOON DILATATION CATHETER

Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K071309
Device Name BLUE MAX BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
two scimed place
maple grove, 
MN 
55311 -1566

Applicant Contact kari christianson
Correspondent
BOSTON SCIENTIFIC CORP.
two scimed place
maple grove, 
MN 
55311 -1566

Correspodent Contact kari christianson
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 05/09/2007
Decision Date 07/13/2007
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