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FDA 510(k)

Aquadex FlexFlow System 2.0

K-Number: K192756 · 2020-02-24

ApplicantChf Solutions, Inc.
Decision Date2020-02-24
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Aquadex FlexFlow System 2.0 is a medical device manufactured by Chf Solutions, Inc.. It received FDA 510(k) clearance on 2020-02-24 under approval number K192756. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquadex FlexFlow System 2.0?

Aquadex FlexFlow System 2.0 is a medical device that received FDA 510(k) clearance on 2020-02-24. It is manufactured by Chf Solutions, Inc.. The 510(k) number is K192756.

When was Aquadex FlexFlow System 2.0 approved by the FDA?

Aquadex FlexFlow System 2.0 received FDA 510(k) clearance on 2020-02-24, under approval number K192756.

What company makes Aquadex FlexFlow System 2.0?

Aquadex FlexFlow System 2.0 is manufactured by Chf Solutions, Inc..

What is the FDA product code for Aquadex FlexFlow System 2.0?

The FDA product code for Aquadex FlexFlow System 2.0 is KDI.

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Official Source

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