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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K914602
Device Name DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED
Applicant
The Heart Valve Div. Medtronic Cardiovascular Surg
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Applicant Contact AMY PETERSON
Correspondent
The Heart Valve Div. Medtronic Cardiovascular Surg
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Correspondent Contact AMY PETERSON
Regulation Number870.3800
Classification Product Code
KRH  
Date Received10/15/1991
Decision Date 11/22/1991
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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