Infusion Catheter Extension Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K023224 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Aquadex System 100, Model A1100

  Class II

  FDA 510(k) K040489 Active Cleared 27 Apr 2004

• System 100; S-100 Ultrafiltration Console; Bdt 500 Ultrafiltration Set

  Class II

  FDA 510(k) K013733 Active Cleared 3 Jun 2002

• Aquadex Flexflow System

  Class II

  FDA 510(k) K071854 Active Cleared 7 Sep 2007

• Aquadex System

  Class II

  FDA 510(k) K050609 Active Cleared 9 Nov 2005

• Modification to Aquadex Flexflow System

  Class II

  FDA 510(k) K062922 Active Cleared 13 Dec 2006

• 5.2F Dual Lumen Extended Length Catheter (DELC)

  Class II

  FDA 510(k) K041791 Active Cleared 10 Sep 2004

See all devices from Chf Solutions, Inc. →

• What is the Infusion Catheter Extension Set designed for?

  The Infusion Catheter Extension Set is designed to extend the length of an infusion catheter, allowing secure and uninterrupted transfer of fluids, medications, or nutrients to patients. It connects between the catheter hub and an infusion line, helping to minimize contamination risk during administration in clinical settings like hospitals, outpatient care, or home infusion therapy.

• How is the Infusion Catheter Extension Set supplied and prepared for use?

  The device is supplied sterile and ready for immediate single-use in clinical settings. No additional processing or preparation is required before use, ensuring convenience and compliance with infection control protocols.

• Is the Infusion Catheter Extension Set reusable or intended for single-use?

  The Infusion Catheter Extension Set is explicitly designed for single-use only. This design choice aligns with best practices for infection control and regulatory standards, ensuring patient safety and device integrity.

• What sizes or models are available for the Infusion Catheter Extension Set?

  The Infusion Catheter Extension Set is available in standard sizes to ensure compatibility with various infusion catheters. While exact dimensions are not specified, the design emphasizes versatility for common clinical applications. Always verify compatibility with your specific catheter system before use.

• How should the Infusion Catheter Extension Set be stored?

  Since the device is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Follow manufacturer guidelines for shelf-life expiration to ensure sterility and performance.