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FDA 510(k)

Kit de Dispositivo de Sistema Aberto 20G Open-System Ally (AV100000), Kit de Dispositivo de Sistema Aberto 22G Open-System Ally (AV110000)

Número K: K220258 · 2022-07-14

RequerenteAvia Vascular
Data da decisão2022-07-14
Código do produtoJKA
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) is the device name listed in this FDA 510(k) record. The listed applicant is Avia Vascular. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K220258. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)?

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Avia Vascular. The 510(k) number is K220258.

When did 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) receive FDA 510(k) clearance?

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) received FDA 510(k) clearance on 2022-07-14, under 510(k) number K220258.

Who is the listed applicant for 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)?

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

What is the FDA product code for 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)?

The FDA product code for 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) is JKA.

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