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Kidney, Artificial, C-DAK 2.0

by Cordis Corp.

510(k) K781237

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781237 Date31 Aug 1978ClearedStatusActive

Official records

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  • Withdrawn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
DJC
Device class
Class II
Regulation
21 CFR Part 862.3610
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Kidney, Artificial, C-DAK 2.0 is a medical device classified as an artificial kidney, designed for hemodialysis to remove waste products and excess fluids from the blood of patients with renal failure. It operates by filtering blood through a semipermeable membrane, mimicking the function of healthy kidneys to maintain electrolyte balance and detoxify the bloodstream during treatment sessions.

This device is supplied as a single-use, sterile system intended for use in clinical settings such as hospitals or dialysis centers. It is regulated under FDA 510(k) clearance (K781237) with a classification of Class II under regulation 862.3610, and was determined to be substantially equivalent to a predicate device. The C-DAK 2.0 model is part of the DJC product code category, with no third-party review involved in its clearance process.

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