The following data is part of a premarket notification filed by Argon Medical Devices with the FDA for Scorpion Portal Vein Access Set.
| Device ID | K213002 |
| 510k Number | K213002 |
| Device Name: | SCORPION Portal Vein Access Set |
| Classification | Introducer, Catheter |
| Applicant | Argon Medical Devices 1445 Flat Creek Road Athens, TX 75751 |
| Contact | Scott Bishop |
| Correspondent | Scott Bishop Argon Medical Devices 1445 Flat Creek Road Athens, TX 75751 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2021-10-14 |