Arstasis, Inc.
Medical device manufacturer in Fremont, CA.
14510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 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 |
| 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 |
| K102728 | Arstasis Access SystemDYB · Special | 10/07/2010SE |
| K100615 | Arstasis Access SystemDYB · Special | 03/30/2010SE |
| K091006 | Itg Vascular Access System, Model 300DYB · Traditional | 02/25/2010SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0993-2011 | Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010…Device has the potential to fracture and sheath separation during use. | 10/19/2010Terminated |