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FDA 510(k)

AVVIGO Guidance System

K-Number: K201713 · 2020-07-23

Decision Date2020-07-23
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVVIGO Guidance System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-07-23 under approval number K201713. 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?

AVVIGO Guidance System is a medical device that received FDA 510(k) clearance on 2020-07-23. It is manufactured by Boston Scientific Corporation. The 510(k) number is K201713.

When was AVVIGO Guidance System approved by the FDA?

AVVIGO Guidance System received FDA 510(k) clearance on 2020-07-23, under approval number K201713.

What company makes AVVIGO Guidance System?

AVVIGO Guidance System is manufactured by Boston Scientific Corporation.

What is the FDA product code for AVVIGO Guidance System?

The FDA product code for AVVIGO 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.