Axera Access System
FDA 510(k) K113110 · Arstasis, Inc.
510(k) numberK113110
Submission
- Device name
- Axera Access System
- Applicant
- Arstasis, Inc.
Redwood City, CA, US - Received
- October 20, 2011
- Decision date
- November 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K123135 | Axera 2 Access System Model AXE200DYB · Traditional | 01/28/2013SE |
| K121521 | Axera Access SystemDYB · Special | 06/21/2012SE |
| K103421 | Arstasis Dilator AdapterDRE · Traditional | 05/24/2011SE |
| K103143 | Arstasis One Latchwire Access SystemDYB · Special | 02/02/2011SE |
Questions and answers
When was Axera Access System cleared by the FDA?
Axera Access System (K113110) received a 510(k) decision of Substantially Equivalent on November 9, 2011, 20 days after the submission was received.
What is the product code of K113110?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.