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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 K922269
Device Name UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493
Applicant
The Heart Valve Div. Medtronic Cardiovascular Surg
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Applicant Contact DIANA K SALDITT
Correspondent
The Heart Valve Div. Medtronic Cardiovascular Surg
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Correspondent Contact DIANA K SALDITT
Regulation Number870.3680
Classification Product Code
LDF  
Date Received05/14/1992
Decision Date 11/23/1992
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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