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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 K961520
Device Name UNIPOLAR IPG GROUND CABLE, MODEL 5473
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact VALERIE K STUHR
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact VALERIE K STUHR
Regulation Number870.3680
Classification Product Code
LDF  
Date Received04/22/1996
Decision Date 11/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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