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DLC 500 Double Lumen Catheter

by Hemodialysis, Division of The

510(k) K781050

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 NumberK781050 Date26 Sep 1978ClearedStatusActive

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  • Withdrawn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 DLC 500 Double Lumen Catheter is a hemodialysis catheter designed for vascular access. It is a double lumen catheter that serves as an accessory in the blood circuit for hemodialysis procedures.

This device is supplied as a single-use catheter and is regulated under FDA 510(k) clearance with product code KOC. The DLC 500 Double Lumen Catheter is manufactured by Hemodialysis, Division of The and was cleared on September 26, 1978.

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 DLC 500 Double Lumen Catheter used for?

    The DLC 500 Double Lumen Catheter is designed for vascular access as an accessory in the blood circuit for hemodialysis procedures. It provides dual lumens for efficient blood flow during dialysis treatments.

  • Is the DLC 500 Double Lumen Catheter single-use or reusable?

    The DLC 500 Double Lumen Catheter is supplied as a single-use catheter, meaning it should be used for one patient procedure only and then discarded to ensure patient safety and prevent cross-contamination.

  • What is the regulatory status of the DLC 500 Double Lumen Catheter?

    The DLC 500 Double Lumen Catheter is regulated under FDA 510(k) clearance with product code KOC. It was cleared on September 26, 1978, and is classified as substantially equivalent to predicate devices in this category.

  • Who manufactures the DLC 500 Double Lumen Catheter?

    The DLC 500 Double Lumen Catheter is manufactured by Hemodialysis, Division of The, with their facility located at 803 N. Front St. Suite 3, Mchenry, IL 60050.