Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)— 510(k) K213638

Substantially Equivalent

Argon Medical Devices

FDA 510(k) clearance K213638 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), Substantially Equivalent on 2021-12-10. Applicant: Argon Medical Devices.

Clearance details

Applicant: Argon Medical Devices
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2021-11-18
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Athens, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.