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5.2F Dual Lumen Extended Length Catheter (DELC)

by Chf Solutions, Inc.

510(k) K041791

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 NumberK041791 Date10 Sep 2004ClearedStatusActive

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  • Withdrawn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
NQJ
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 5.2F Dual Lumen Extended Length Catheter (DELC) is a 16-gauge polyurethane catheter with a 304 stainless steel coil to prevent kinking. It features a dual-lumen proximal section with double-D configuration fused to a single-lumen distal section, providing peripheral venous access for ultrafiltration to facilitate blood removal and return.

The catheter is supplied with a flexible hub with suture wings for skin securement. It is intended for short-term peripheral venous access and is available in the 5.2F size. The device has FDA 510K clearance (K041791) and is classified under product code NQJ for gastroenterology and urology use.

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Questions

AI-generated answers, 22 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 5.2F Dual Lumen Catheter used for?

    The 5.2F Dual Lumen Catheter is used for short-term peripheral venous access to facilitate ultrafiltration and blood removal.

  • What material is the catheter made of?

    The catheter is made of polyurethane with a 304 stainless steel coil to prevent kinking.

  • Is the catheter supplied with any additional features?

    Yes, the catheter is supplied with a flexible hub and suture wings for skin securement.

  • What size is the catheter available in?

    The catheter is available in the 5.2F size.