K201489 is an FDA 510(k) clearance for the Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 22, 2020, 201 days after receiving the submission on June 4, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K201489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2020 |
| Decision Date | December 22, 2020 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |