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510(k) K181132

Tri-Ad 2.0 Adams Tricuspid Band by Medtronic — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2018
Date Received
April 30, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
Review Panel
CV
Submission Type

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