# K182957: Heli-FX EndoAnchor System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular, Inc.
- Decided: Nov 21, 2018 after 28 days
- Product code: OTD (Endovascular Suturing System)
- Device class: 2
- Regulation: 21 CFR 870.3460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN100026 (2011). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171427: Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette, Medtronic Vascular, Inc. (2017) Summary page 5.

## Indications for use
The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

Source page: https://510kreport.com/device/K182957
Methodology: https://510kreport.com/methodology