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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 K941137
Device Name SCIMED TRIGUIDE GUIDING CATHETER
Original Applicant
SCIMED LIFE SYSTEMS, INC.
2010 east center circle
plymouth,  MN  55441 2644
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/10/1994
Decision Date 06/22/1994
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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