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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K842065
Device Name EPICARDIAL, UNIPOLAR LEAD 4951
Applicant
Medtronic Vascular
P.O. Box 1453
Minneapolis,  MN  55440
Applicant Contact EDWARD W NUMAINVILL
Correspondent
Medtronic Vascular
P.O. Box 1453
Minneapolis,  MN  55440
Correspondent Contact EDWARD W NUMAINVILL
Regulation Number870.3620
Classification Product Code
DTD  
Date Received05/22/1984
Decision Date 01/18/1985
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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