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FDA 510(k)

Optiflux Enexa F500 Dialyzer

K-Number: K192928 · 2020-07-09

ApplicantFresenius Medical Care Reanal Therapies Group, LLC
Decision Date2020-07-09
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Optiflux Enexa F500 Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K192928. 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 Optiflux Enexa F500 Dialyzer?

Optiflux Enexa F500 Dialyzer is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. The 510(k) number is K192928.

When did Optiflux Enexa F500 Dialyzer receive FDA 510(k) clearance?

Optiflux Enexa F500 Dialyzer received FDA 510(k) clearance on 2020-07-09, under 510(k) number K192928.

Who is the listed applicant for Optiflux Enexa F500 Dialyzer?

The FDA 510(k) record lists Fresenius Medical Care Reanal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optiflux Enexa F500 Dialyzer?

The FDA product code for Optiflux Enexa F500 Dialyzer 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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