Home / 510(k) Clearances / K161287

510(k) K161287

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak by Medtronic Vascular — Product Code DQO

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
August 19, 2016
Date Received
May 9, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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