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FDA 510(k)

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

Número K: K213638 · 2021-12-10

RequerenteArgon Medical Devices
Data da decisão2021-12-10
Código do produtoDYB
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K213638. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is 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)?

Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Argon Medical Devices. The 510(k) number is K213638.

When did Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) receive FDA 510(k) clearance?

Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) received FDA 510(k) clearance on 2021-12-10, under 510(k) number K213638.

Who is the listed applicant 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)?

The FDA 510(k) record lists Argon Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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)?

The FDA product code 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) is DYB.

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Dispositivos Relacionados (Código: DYB)

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Fonte oficial

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