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510(k) K213531

TR BAND Radial Compression Device by Terumo Medical Corporation — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2021
Date Received
November 5, 2021
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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