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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 K922611
Device Name SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
Original Applicant
SCIMED LIFE SYSTEMS, INC.
6655 wedgwood rd.
maple grove,  MN  55369
Original Contact mercedes p bayani
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/02/1992
Decision Date 01/11/1993
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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