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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 K810041
Device Name CORDIS TEMPORATY CURVED ATRIAL LEAD
Applicant
Cordis Corp.
MD 
Correspondent
Cordis Corp.
MD 
Regulation Number870.3680
Classification Product Code
LDF  
Date Received01/07/1981
Decision Date 02/05/1981
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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