# K140036: Aptus Heli-FX Guide - 22CM Deflectable Length; Aptus Heli-FX Guide - 28CM Deflectable Length; Aptus Heli-FX Applier with

- Pathway: 510(k) (Special)
- Applicant: Aptus Endosystems, Inc.
- Decided: Feb 6, 2014 after 30 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: 3 generations back to DEN100026 (2011). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN100026: Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette, Aptus Endosystems, Inc. (2011). Our reading of the summary gave K102333, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN100026, Aptus Steerable Endoguide with Obturator, Aptus Endostaple… (Aptus Endosystems, Inc.), granted Nov 21, 2011; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K121168: Aptus 18FR Helifx Guide-22 Deflectable Length, Aptus Endosystems, Inc. (2012) Summary page 1.
- K130677: Aptus Heli-FX Aortic Securement System, Aptus Endosystems, Inc. (2013) Summary page 1.

## Most influential descendants
- K141041: Aptus Heli-FX Ancillary Endoanchor Cassette (2014), 2 descendants of its own
- K171427: Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (2017), 1 descendant of its own
- K182957: Heli-FX EndoAnchor System (2018), 0 descendants of its own

## 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 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/K140036
Methodology: https://510kreport.com/methodology