FDA 510(k)

DCwire Micro-guidewire

N.º K: K252122 · 2026-03-16

SolicitanteShanghai Achieva Medical Suzhou Co., Ltd.

Fecha de decisión2026-03-16

Código de productoMOF

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

DCwire Micro-guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Achieva Medical Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K252122. 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 DCwire Micro-guidewire?

DCwire Micro-guidewire is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Shanghai Achieva Medical Suzhou Co., Ltd.. The 510(k) number is K252122.

When did DCwire Micro-guidewire receive FDA 510(k) clearance?

DCwire Micro-guidewire received FDA 510(k) clearance on 2026-03-16, under 510(k) number K252122.

Who is the listed applicant for DCwire Micro-guidewire?

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

What is the FDA product code for DCwire Micro-guidewire?

The FDA product code for DCwire Micro-guidewire is MOF.

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Fuente oficial

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