The following data is part of a premarket notification filed by Arstasis, Inc. with the FDA for Axera 2 Access System Model Axe200.
| Device ID | K123135 |
| 510k Number | K123135 |
| Device Name: | AXERA 2 ACCESS SYSTEM MODEL AXE200 |
| Classification | Introducer, Catheter |
| Applicant | ARSTASIS, INC. 740 BAY RD Redwood City, CA 94063 |
| Contact | Debra Cogan |
| Correspondent | Debra Cogan ARSTASIS, INC. 740 BAY RD Redwood City, CA 94063 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2013-01-28 |
| Summary: | summary |