# K032105: Endohelix Endarterectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Endarx, Inc.
- Decided: Oct 30, 2003 after 114 days
- Product code: DWX (Stripper, Artery, Intraluminal)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904944 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904944: Transluminal Endarterectomy Device, Baxter Healthcare Corp (1990) Summary page 1.
- K003719: Vascular Architects Periscope Device, Vascular Architects, Inc. (2001)

## Indications for use
The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.

Source page: https://510kreport.com/device/K032105
Methodology: https://510kreport.com/methodology