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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 K861082
Device Name CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
Original Applicant
CORDIS CORP.
p.o. box 025700
miami,  FL  33102
Original Contact donna l rogers
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/21/1986
Decision Date 05/05/1986
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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