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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 K911236
Device Name MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
Original Applicant
MEDTRONIC VASCULAR
7000 central ave. n.e.
minneapolis,  MN  55432
Original Contact tracy a malm
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/20/1991
Decision Date 06/18/1991
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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