K213638 is an FDA 510(k) clearance for the Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003). This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Argon Medical Devices (Athens, US). The FDA issued a Cleared decision on December 10, 2021, 22 days after receiving the submission on November 18, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K213638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2021 |
| Decision Date | December 10, 2021 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |