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C-DAK Artificial Kidney

by Cordis Corp.

510(k) K830729

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830729 Date29 Mar 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KOC
Device class
Class II
Regulation
21 CFR Part 876.5820
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 C-DAK Artificial Kidney is a hemodialysis device designed to perform artificial kidney function. It is classified as a dialyzer with capillary hollow fiber technology, intended for use in blood circuit procedures.

This device is supplied as a Class II medical device with special controls, cleared by the FDA under 510(k) K830729. It is manufactured by Cordis Corp. and is not specified as single-use or reusable in the provided data. The device is MRI safe and has various model numbers including C-DAK 2100.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Questions

AI-generated answers, 28 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 C-DAK Artificial Kidney used for?

    The C-DAK Artificial Kidney is a hemodialysis device designed to perform artificial kidney function. It is classified as a dialyzer with capillary hollow fiber technology, intended for use in blood circuit procedures.

  • Is the C-DAK Artificial Kidney single-use or reusable?

    The provided data does not specify whether the C-DAK Artificial Kidney is single-use or reusable. It is supplied as a Class II medical device with special controls.

  • What are the model numbers available for the C-DAK Artificial Kidney?

    The C-DAK Artificial Kidney has various model numbers, including C-DAK 2100. Each model may have specific specifications or features designed for different clinical applications.

  • What is the regulatory status of the C-DAK Artificial Kidney?

    The C-DAK Artificial Kidney is cleared by the FDA under 510(k) K830729 as a Class II medical device with special controls. It is manufactured by Cordis Corp. and is MRI safe.