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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 K893678
Device Name DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
Applicant
Medtronic Blood Systems, Inc.
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Applicant Contact AMY PETERSON
Correspondent
Medtronic Blood Systems, Inc.
7000 Central Ave., NE
P.O. Box 1350
Minneapolis,  MN  55440
Correspondent Contact AMY PETERSON
Regulation Number870.3800
Classification Product Code
KRH  
Date Received05/16/1989
Decision Date 11/27/1989
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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