FDA 510(k)

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

Número K: K173871 · 2018-09-17

RequerenteSuzhou Hengrui Callisyn Biomedical Co., Ltd.

Data da decisão2018-09-17

Código do produtoNAJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Callisyn Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2018-09-17 under 510(k) number K173871. The device is classified under product code NAJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is a medical device that received FDA 510(k) clearance on 2018-09-17. The listed applicant is Suzhou Hengrui Callisyn Biomedical Co., Ltd.. The 510(k) number is K173871.

When did CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres receive FDA 510(k) clearance?

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres received FDA 510(k) clearance on 2018-09-17, under 510(k) number K173871.

Who is the listed applicant for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?

The FDA 510(k) record lists Suzhou Hengrui Callisyn Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?

The FDA product code for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is NAJ.

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Fonte oficial

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