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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 K944537
Device Name SCIMED TRIGUIDE GUIDE CATHETER
Original Applicant
SCIMED LIFE SYSTEMS, INC.
8200 scimed place
maple grove,  MN  55311 1566
Original Contact diane m lowe
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/15/1994
Decision Date 10/21/1994
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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