FDA 510(k)

Synxess Neurovascular Guidewire

N.º K: K240871 · 2024-11-18

SolicitanteEnlight Medical Technologies (Shenzhen) Co., Ltd.

Fecha de decisión2024-11-18

Código de productoMOF

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Synxess Neurovascular Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Enlight Medical Technologies (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-11-18 under 510(k) number K240871. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Synxess Neurovascular Guidewire?

Synxess Neurovascular Guidewire is a medical device that received FDA 510(k) clearance on 2024-11-18. The listed applicant is Enlight Medical Technologies (Shenzhen) Co., Ltd.. The 510(k) number is K240871.

When did Synxess Neurovascular Guidewire receive FDA 510(k) clearance?

Synxess Neurovascular Guidewire received FDA 510(k) clearance on 2024-11-18, under 510(k) number K240871.

Who is the listed applicant for Synxess Neurovascular Guidewire?

The FDA 510(k) record lists Enlight Medical Technologies (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synxess Neurovascular Guidewire?

The FDA product code for Synxess Neurovascular Guidewire is MOF.

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Fuente oficial

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