FDA 510(k)

Disposable High-pressure Extension Lines

Número K: K230668 · 2024-06-14

RequerentePrecision Medical Plastics , Ltd.

Data da decisão2024-06-14

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable High-pressure Extension Lines is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical Plastics , Ltd.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K230668. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable High-pressure Extension Lines?

Disposable High-pressure Extension Lines is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Precision Medical Plastics , Ltd.. The 510(k) number is K230668.

When did Disposable High-pressure Extension Lines receive FDA 510(k) clearance?

Disposable High-pressure Extension Lines received FDA 510(k) clearance on 2024-06-14, under 510(k) number K230668.

Who is the listed applicant for Disposable High-pressure Extension Lines?

The FDA 510(k) record lists Precision Medical Plastics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable High-pressure Extension Lines?

The FDA product code for Disposable High-pressure Extension Lines is DXT.

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Fonte oficial

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