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FDA 510(k)

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

K-Number: K193509 · 2020-01-17

ApplicantAcutus Medical, Inc.
Decision Date2020-01-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2020-01-17 under approval number K193509. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX?

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K193509.

When was AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX approved by the FDA?

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX received FDA 510(k) clearance on 2020-01-17, under approval number K193509.

What company makes AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX?

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is manufactured by Acutus Medical, Inc..

What is the FDA product code for AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX?

The FDA product code for AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is DYB.

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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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