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510(k) K162027

TRAcelet Compression Device by Medtronic Vascular — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2016
Date Received
July 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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