FDA 510(k)

WAVE Clinical Platform (2.0.000)

Número K: K250135 · 2026-01-16

RequerenteBaxter Healthcare Corp/ Excel Medical

Data da decisão2026-01-16

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

WAVE Clinical Platform (2.0.000) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp/ Excel Medical. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K250135. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WAVE Clinical Platform (2.0.000)?

WAVE Clinical Platform (2.0.000) is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Baxter Healthcare Corp/ Excel Medical. The 510(k) number is K250135.

When did WAVE Clinical Platform (2.0.000) receive FDA 510(k) clearance?

WAVE Clinical Platform (2.0.000) received FDA 510(k) clearance on 2026-01-16, under 510(k) number K250135.

Who is the listed applicant for WAVE Clinical Platform (2.0.000)?

The FDA 510(k) record lists Baxter Healthcare Corp/ Excel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVE Clinical Platform (2.0.000)?

The FDA product code for WAVE Clinical Platform (2.0.000) is MWI.

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Fonte oficial

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