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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 K882045
Device Name HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
Applicant
Cordis Leads, Inc.
7400 Tucson Way
Englewood,  CO  80112
Applicant Contact DUANE A SCHULTZ
Correspondent
Cordis Leads, Inc.
7400 Tucson Way
Englewood,  CO  80112
Correspondent Contact DUANE A SCHULTZ
Regulation Number870.3680
Classification Product Code
LDF  
Date Received05/16/1988
Decision Date 07/12/1988
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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