AXERA 2 Access System
by Arstasis, Inc. 510(k) 4 variants
Active
510(k) K140871
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140871 | Date6 Jun 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The AXERA 2 Access System is a device 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. It is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
The AXERA 2 Access System is manufactured by Arstasis, Inc. and was cleared by the FDA via the 510(k) pathway on June 6, 2014. It is classified as a Class 2 device under product code DYB. The system is supplied as a single-use device and requires appropriate storage conditions as specified by the manufacturer.
Other devices from Arstasis, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the AXERA 2 Access System used for?
The AXERA 2 Access System is designed 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 during diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
How is the AXERA 2 Access System supplied?
The AXERA 2 Access System is supplied as a single-use device and requires appropriate storage conditions as specified by the manufacturer, Arstasis, Inc. It is important to follow the manufacturer's storage guidelines to maintain device integrity.
What is the regulatory status of the AXERA 2 Access System?
The AXERA 2 Access System was cleared by the FDA via the 510(k) pathway on June 6, 2014. It is classified as a Class 2 device under product code DYB and was determined to be substantially equivalent to predicate devices.
What sizes and models of the AXERA 2 Access System are available?
The AXERA 2 Access System is indicated for use with 5F or 6F introducer sheaths in diagnostic femoral artery catheterization procedures. The device is designed specifically for these sizes and should not be used with other introducer sheath sizes.