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Endologix AFX Introducer System

by Endologix LLC

510(k) K111747

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111747↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK111747 Date12 Jul 2011ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111747 decided 12 Jul 2011 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DYB
FDA applicant
Endologix, Inc.
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Endologix AFX Introducer System is a vascular access device designed for the introduction of endovascular therapies, specifically within the aortic arch and peripheral arteries. It facilitates the delivery of endografts and other interventional devices used in the treatment of aortic aneurysms and related vascular pathologies, ensuring precise placement and deployment.

This system is supplied sterile and intended for single-use in controlled clinical settings such as catheterization labs or operating rooms. It is classified under product code DYB and has received FDA 510(k) clearance under a Special review process, with a decision date of July 12, 2011. Compliance with the Medical Device Directive (MDD) is also noted. The system is engineered for compatibility with fluoroscopic imaging and adheres to regulatory standards for endovascular access devices.

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