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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 K940545
Device Name SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH
Original Applicant
SCIMED LIFE SYSTEMS, INC.
2010 east center circle
plymouth,  MN  55441 -2644
Original Contact diane m lowe
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/07/1994
Decision Date 05/06/1994
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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