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Altra Flux 200 Hemodialyzer

by Althin Medical AB an Affiliate of Baxter Intl 2 variants

510(k) K970679

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970679 Date23 Jul 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MSF
Device Class
Class II
Regulation
21 CFR Part 876.5860
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Altra Flux 200 Hemodialyzer is a hemodialyzer used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. It is designed for use in extracorporeal blood circuits where blood flows through arterial tubing to the blood compartment of the device.

The device is supplied as a multiple-use hemodialyzer with reuse labeling and is classified as a Class II medical device under FDA regulation number 876.5860. It received FDA 510(k) clearance (K970679) on July 23, 1998, and is manufactured by Althin Medical AB, an affiliate of Baxter Intl, with product code MSF and advisory committee assignment to Gastroenterology and Urology (GU).

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Altra Flux 200 Hemodialyzer used for?

    The Altra Flux 200 Hemodialyzer is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure by removing waste and excess fluid from the blood during extracorporeal circulation.

  • Is the Altra Flux 200 Hemodialyzer designed for single-use or multiple-use?

    The Altra Flux 200 Hemodialyzer is supplied as a multiple-use device with reuse labeling, meaning it is intended to be reprocessed and used more than once following validated cleaning and disinfection procedures.

  • What regulatory pathway was used for the Altra Flux 200 Hemodialyzer?

    The Altra Flux 200 Hemodialyzer received FDA 510(k) clearance (K970679) on July 23, 1998, as a substantially equivalent device under regulation number 876.5860, classified as a Class II medical device.