FDA 510(k)

Kodiak™ Dual Port Coaxial Introducer Kit

Número K: K230631 · 2023-05-22

Data da decisão2023-05-22

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kodiak™ Dual Port Coaxial Introducer Kit 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 2023-05-22 under 510(k) number K230631. 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 Kodiak™ Dual Port Coaxial Introducer Kit?

Kodiak™ Dual Port Coaxial Introducer Kit is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Argon Medical Devices. The 510(k) number is K230631.

When did Kodiak™ Dual Port Coaxial Introducer Kit receive FDA 510(k) clearance?

Kodiak™ Dual Port Coaxial Introducer Kit received FDA 510(k) clearance on 2023-05-22, under 510(k) number K230631.

Who is the listed applicant for Kodiak™ Dual Port Coaxial Introducer Kit?

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 Kodiak™ Dual Port Coaxial Introducer Kit?

The FDA product code for Kodiak™ Dual Port Coaxial Introducer Kit is DYB.

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Fonte oficial

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