FDA 510(k)

Stent Positioning Assistance System (SPAS)

Número K: K221917 · 2022-08-19

Data da decisão2022-08-19

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stent Positioning Assistance System (SPAS) is the device name listed in this FDA 510(k) record. The listed applicant is Seven Sons , Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K221917. 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 Stent Positioning Assistance System (SPAS)?

Stent Positioning Assistance System (SPAS) is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Seven Sons , Ltd.. The 510(k) number is K221917.

When did Stent Positioning Assistance System (SPAS) receive FDA 510(k) clearance?

Stent Positioning Assistance System (SPAS) received FDA 510(k) clearance on 2022-08-19, under 510(k) number K221917.

Who is the listed applicant for Stent Positioning Assistance System (SPAS)?

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

What is the FDA product code for Stent Positioning Assistance System (SPAS)?

The FDA product code for Stent Positioning Assistance System (SPAS) is DQX.

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