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FDA 510(k)

AVVIGO Guidance System II

K-Number: K212490 · 2021-10-20

ApplicantBoston Scientific Corporation
Decision Date2021-10-20
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVVIGO Guidance System II is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-10-20 under approval number K212490. 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 Guidance System II?

AVVIGO Guidance System II is a medical device that received FDA 510(k) clearance on 2021-10-20. It is manufactured by Boston Scientific Corporation. The 510(k) number is K212490.

When was AVVIGO Guidance System II approved by the FDA?

AVVIGO Guidance System II received FDA 510(k) clearance on 2021-10-20, under approval number K212490.

What company makes AVVIGO Guidance System II?

AVVIGO Guidance System II is manufactured by Boston Scientific Corporation.

What is the FDA product code for AVVIGO Guidance System II?

The FDA product code for AVVIGO Guidance System II is DQK.

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Related PubMed Literature

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Official Source

View on FDA Database →

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

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