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510(k) K182957

Heli-FX EndoAnchor System by Medtronic Vascular, Inc. — Product Code OTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2018
Date Received
October 24, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endovascular Suturing System
Device Class
Class II
Regulation Number
870.3460
Review Panel
CV
Submission Type

Provides fixation and sealing between and endovascular graft and the native artery.

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