FDA 510(k)

Wattson temporary pacing guidewire (2250)

Número K: K230637 · 2023-05-05

Data da decisão2023-05-05

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wattson temporary pacing guidewire (2250) is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K230637. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wattson temporary pacing guidewire (2250)?

Wattson temporary pacing guidewire (2250) is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K230637.

When did Wattson temporary pacing guidewire (2250) receive FDA 510(k) clearance?

Wattson temporary pacing guidewire (2250) received FDA 510(k) clearance on 2023-05-05, under 510(k) number K230637.

Who is the listed applicant for Wattson temporary pacing guidewire (2250)?

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

What is the FDA product code for Wattson temporary pacing guidewire (2250)?

The FDA product code for Wattson temporary pacing guidewire (2250) is DQX.

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Fonte oficial

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