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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K914046
Device Name THE BIG EASY Y-ADAPTER
Original Applicant
MICROVENA CORP.
3600 labore rd. #1
vadnais heights,  MN  55110
Original Contact rudy mazzocchi
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/10/1991
Decision Date 11/08/1991
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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