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Mca 200 Hempdialyzer

by Althin Medical AB an Affiliate of Baxter Intl

510(k) K926372

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 NumberK926372 Date13 Feb 1995ClearedStatusActive

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  • Withdrawn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
FJI
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Mca 200 Hempdialyzer is a hollow fiber capillary dialyzer. It is designed to facilitate the process of hemodialysis by providing a membrane for the exchange of solutes between blood and dialysate.

This device is regulated under FDA 510K clearance as a class 2 medical device. It is identified by product code FJI and is intended for use in clinical settings as specified by the manufacturer.

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Questions

AI-generated answers, 23 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 primary function of the MCA 200 Hempdialyzer?

    The MCA 200 Hempdialyzer is a hollow fiber capillary dialyzer designed to facilitate hemodialysis. It functions by providing a specialized membrane that allows for the exchange of solutes between a patient's blood and the dialysate solution.

  • What is the regulatory classification of this device?

    This device is regulated as a class 2 medical device under FDA 510K clearance. It is identified by product code FJI and is intended for use in clinical settings as specified by the manufacturer.

  • Who is the manufacturer of the MCA 200 Hempdialyzer?

    The MCA 200 Hempdialyzer is manufactured by Althin Medical AB, which is an affiliate of Baxter International, located in Miami Lakes, Florida.