FDA 510(k)

Drakon™ and Sequre® Microcatheters

Número K: K231293 · 2023-06-01

Data da decisão2023-06-01

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Drakon™ and Sequre® Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Medical Therapeutics. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K231293. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Drakon™ and Sequre® Microcatheters?

Drakon™ and Sequre® Microcatheters is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Accurate Medical Therapeutics. The 510(k) number is K231293.

When did Drakon™ and Sequre® Microcatheters receive FDA 510(k) clearance?

Drakon™ and Sequre® Microcatheters received FDA 510(k) clearance on 2023-06-01, under 510(k) number K231293.

Who is the listed applicant for Drakon™ and Sequre® Microcatheters?

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

What is the FDA product code for Drakon™ and Sequre® Microcatheters?

The FDA product code for Drakon™ and Sequre® Microcatheters is DQO.

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Fonte oficial

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