.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K111295
Device Name .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
Applicant
Boston Scientific Corporation
one scimed place
maple grove, 
MN 
55311

Applicant Contact mark murphy
Correspondent
Boston Scientific Corporation
one scimed place
maple grove, 
MN 
55311

Correspodent Contact mark murphy
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 05/10/2011
Decision Date 05/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls