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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K021735
Device Name BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact CANDICE BURNS
Correspondent
BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact CANDICE BURNS
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received05/28/2002
Decision Date 08/08/2002
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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