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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sizer, Heart-Valve, Prosthesis
510(k) Number K852612
Device Name METRONIC MODEL F7700 HEART VALVE SIZERS
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact PAM SINNOTT
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact PAM SINNOTT
Regulation Number870.3945
Classification Product Code
DTI  
Date Received06/19/1985
Decision Date 09/23/1985
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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