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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 K934988
Device Name 9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
Original Applicant
SCIMED LIFE SYSTEMS, INC.
2010 east center circle
plymouth,  MN  55441 2644
Original Contact deborah l jensen
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/18/1993
Decision Date 01/14/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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