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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K851913
Device Name CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact BETTY HERNANCEL
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact BETTY HERNANCEL
Regulation Number870.3680
Classification Product Code
LDF  
Date Received05/01/1985
Decision Date 09/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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