Axera 2 Access System Model AXE200

Q: What is the product code of K123135?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.

FDA 510(k) K123135 · Arstasis, Inc.

Substantially Equivalent

510(k) numberK123135

Submission

Device name: Axera 2 Access System Model AXE200
Applicant: Arstasis, Inc.
Redwood City, CA, US
Received: October 5, 2012
Decision date: January 28, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DYB – Introducer, Catheter
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1340
Specialty: Cardiovascular

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More from Protaryx Medical, Inc.

510(k)	Device	Decision
K151877	MicroTract Access SystemDRE · Special	08/07/2015SE
K140871	Axera 2 Access SystemDYB · Special	06/06/2014SE
K140287	Axera RX Access SystemDYB · Traditional	05/16/2014SE
K140201	Axera 2 Access SystemDYB · Traditional	03/28/2014SE
K132263	Axera 2 Access SystemDYB · Special	08/19/2013SE
K123618	Axera 2 Access SystemDYB · Traditional	03/24/2013SE
K121521	Axera Access SystemDYB · Special	06/21/2012SE
K113110	Axera Access SystemDYB · Special	11/09/2011SE
K103421	Arstasis Dilator AdapterDRE · Traditional	05/24/2011SE
K103143	Arstasis One Latchwire Access SystemDYB · Special	02/02/2011SE

Questions and answers

When was Axera 2 Access System Model AXE200 cleared by the FDA?

Axera 2 Access System Model AXE200 (K123135) received a 510(k) decision of Substantially Equivalent on January 28, 2013, 115 days after the submission was received.

What is the product code of K123135?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.