FDA 510(k)

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

Número K: K243432 · 2025-07-22

Data da decisão2025-07-22

Código do produtoOWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K243432. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Brainlab AG. The 510(k) number is K243432.

When did Vascular Navigation PAD 2.0; Navigation Software Vascular PAD receive FDA 510(k) clearance?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243432.

Who is the listed applicant for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

The FDA product code for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is OWB.

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Outros registros que listam Brainlab AG como candidato(a)

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