FDA 510(k)

AVVIGO™+ Multi-Modality Guidance System

Número K: K253692 · 2026-08-21

Data da decisão2026-08-21

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AVVIGO™+ Multi-Modality Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K253692. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AVVIGO™+ Multi-Modality Guidance System?

AVVIGO™+ Multi-Modality Guidance System is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Boston Scientific. The 510(k) number is K253692.

When did AVVIGO™+ Multi-Modality Guidance System receive FDA 510(k) clearance?

AVVIGO™+ Multi-Modality Guidance System received FDA 510(k) clearance on 2026-08-21, under 510(k) number K253692.

Who is the listed applicant for AVVIGO™+ Multi-Modality Guidance System?

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

What is the FDA product code for AVVIGO™+ Multi-Modality Guidance System?

The FDA product code for AVVIGO™+ Multi-Modality Guidance System is DQK.

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Fonte oficial

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