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FDA 510(k)

AVVIGO'+ Multi-Modality Guidance System

K-Number: K230884 · 2023-09-26

Decision Date2023-09-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVVIGO'+ Multi-Modality Guidance System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-09-26 under approval number K230884. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

AVVIGO'+ Multi-Modality Guidance System is a medical device that received FDA 510(k) clearance on 2023-09-26. It is manufactured by Boston Scientific Corporation. The 510(k) number is K230884.

When was AVVIGO'+ Multi-Modality Guidance System approved by the FDA?

AVVIGO'+ Multi-Modality Guidance System received FDA 510(k) clearance on 2023-09-26, under approval number K230884.

What company makes AVVIGO'+ Multi-Modality Guidance System?

AVVIGO'+ Multi-Modality Guidance System is manufactured by Boston Scientific Corporation.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.