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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K934191
Device Name NEW BLUE MAX BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Applicant Contact PAMELA L CADORETTE
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Correspondent Contact PAMELA L CADORETTE
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/26/1993
Decision Date 12/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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