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FDA 510(k)

DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY

K-Number: K913950 · 1991-11-01

ApplicantAlthin Medical AB an Affiliate of Baxter Intl
Decision Date1991-11-01
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. It received FDA 510(k) clearance on 1991-11-01 under 510(k) number K913950. 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 DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY?

DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY is a medical device that received FDA 510(k) clearance on 1991-11-01. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. The 510(k) number is K913950.

When did DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY receive FDA 510(k) clearance?

DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY received FDA 510(k) clearance on 1991-11-01, under 510(k) number K913950.

Who is the listed applicant for DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY?

The FDA 510(k) record lists Althin Medical AB an Affiliate of Baxter Intl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY?

The FDA product code for DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY is KDI.

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Other records listing Althin Medical AB an Affiliate of Baxter Intl as applicant

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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.

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