Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Chf Solutions, Inc.. It received FDA 510(k) clearance on 2020-02-24 under 510(k) 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. The listed applicant is Chf Solutions, Inc.. The 510(k) number is K192756.

When did Aquadex FlexFlow System 2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Aquadex FlexFlow System 2.0?

The FDA 510(k) record lists Chf Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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.

↑