FDA 510(k)

Embozene Color-Advanced Microspheres

Número K: K180102 · 2018-04-19

Data da decisão2018-04-19

Código do produtoNOY

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Embozene Color-Advanced Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K180102. The device is classified under product code NOY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Embozene Color-Advanced Microspheres?

Embozene Color-Advanced Microspheres is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Boston Scientific. The 510(k) number is K180102.

When did Embozene Color-Advanced Microspheres receive FDA 510(k) clearance?

Embozene Color-Advanced Microspheres received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180102.

Who is the listed applicant for Embozene Color-Advanced Microspheres?

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

What is the FDA product code for Embozene Color-Advanced Microspheres?

The FDA product code for Embozene Color-Advanced Microspheres is NOY.

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Fonte oficial

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