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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 K943622
Device Name SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Applicant Contact LARS BANSBERG, PH.D.
Correspondent
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Correspondent Contact LARS BANSBERG, PH.D.
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/27/1994
Decision Date 11/30/1994
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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