FDA 510(k)

AngioWaveNet

Número K: K244002 · 2025-09-10

Data da decisão2025-09-10

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

AngioWaveNet is the device name listed in this FDA 510(k) record. The listed applicant is Angiowave Imaging, Inc.. It received FDA 510(k) clearance on 2025-09-10 under 510(k) number K244002. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AngioWaveNet?

AngioWaveNet is a medical device that received FDA 510(k) clearance on 2025-09-10. The listed applicant is Angiowave Imaging, Inc.. The 510(k) number is K244002.

When did AngioWaveNet receive FDA 510(k) clearance?

AngioWaveNet received FDA 510(k) clearance on 2025-09-10, under 510(k) number K244002.

Who is the listed applicant for AngioWaveNet?

The FDA 510(k) record lists Angiowave Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AngioWaveNet?

The FDA product code for AngioWaveNet is QIH.

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