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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 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
Correspondent Contact KARI CHRISTIANSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/09/2007
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
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