# K111747: Endologix Afx Introducer System

- Pathway: 510(k) (Special)
- Applicant: Endologix, Inc.
- Decided: Jul 12, 2011 after 20 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K032073 (2003). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110090: Afx Introducer System, Endologix, Inc. (2011) Summary page 2.

## Most influential descendants
- K120212: Afx Introducer System (2012), 5 descendants of its own
- K141275: Endophys Pressure Sensing Sheath Kit (2015), 4 descendants of its own
- K160272: Endophys Pressure Sensing Sheath Kit (2016), 3 descendants of its own
- K173399: Endophys Pressure Sensing Sheath Kit- 8F (2017), 1 descendant of its own
- K190098: Endophys Pressure Sensing Sheath (2019), 0 descendants of its own

## Indications for use
The Endologix AFX Introducer Systems are intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

Source page: https://510kreport.com/device/K111747
Methodology: https://510kreport.com/methodology