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FDA 510(k)

AF-150 HEMODIALYZER

K-Number: K992566 · 2000-01-18

ApplicantAlthin Medical AB
Decision Date2000-01-18
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AF-150 HEMODIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K992566. 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 AF-150 HEMODIALYZER?

AF-150 HEMODIALYZER is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Althin Medical AB. The 510(k) number is K992566.

When did AF-150 HEMODIALYZER receive FDA 510(k) clearance?

AF-150 HEMODIALYZER received FDA 510(k) clearance on 2000-01-18, under 510(k) number K992566.

Who is the listed applicant for AF-150 HEMODIALYZER?

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

What is the FDA product code for AF-150 HEMODIALYZER?

The FDA product code for AF-150 HEMODIALYZER is KDI.

Related Clinical Trials

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.

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Other records listing Althin Medical AB as applicant

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.

K992573AF-220 HEMODIALYZERK992563A-22 HEMODIALYZERK992564AF-180 HEMODIALYZERK992594A-15 HEMODIALYZERK992565A-18 HEMODIALYZERK990010ALTHIN MEDICAL AB ALTRACART II

View all 7 devices →

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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