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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-10-20 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K212490.

When did AVVIGO Guidance System II receive FDA 510(k) clearance?

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

Who is the listed applicant for AVVIGO Guidance System II?

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

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 Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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