# K140871: Axera 2 Access System

- Pathway: 510(k) (Special)
- Applicant: Arstasis, Inc.
- Decided: Jun 6, 2014 after 63 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: 14 generations back to K945616 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140201: Axera 2 Access System, Arstasis, Inc. (2014) Summary page 1.

## Indications for use
The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

Source page: https://510kreport.com/device/K140871
Methodology: https://510kreport.com/methodology