The following data is part of a premarket notification filed by Argon Medical Devices with the FDA for Traveler 0.038 Stylet Portal Vein Access (tps001), Traveler 21ga Needle Portal Vein Access Set (tps002), Traveler 16ga Needle Portal Vein Access Set (tps003).
| Device ID | K213638 |
| 510k Number | K213638 |
| Device Name: | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) |
| Classification | Introducer, Catheter |
| Applicant | Argon Medical Devices 1445 Flat Creek Road Athens, TX 75751 |
| Contact | Ana Jimenez-hughes |
| Correspondent | Ana Jimenez-hughes 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 | 2021-11-18 |
| Decision Date | 2021-12-10 |