FDA 510(k)

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire

Número K: K212167 · 2022-02-09

Data da decisão2022-02-09

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire 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 2022-02-09 under 510(k) number K212167. 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 R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K212167.

When did R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire receive FDA 510(k) clearance?

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire received FDA 510(k) clearance on 2022-02-09, under 510(k) number K212167.

Who is the listed applicant for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

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 R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

The FDA product code for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is DQX.

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Fonte oficial

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