Vascular-Access Port Change Catheter LJT

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

Full name

Vascular-Access Port Change Catheter

510(k) Number

K841150 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Norfolk Medical NorPort

  Class II

  FDA 510(k) K871209 Active Cleared 24 Jun 1987

• Norfolk Medical Peritoneal-Access Port

  Class III

  FDA 510(k) K854593 Active Cleared 4 Feb 1986

• Vascular Access Port Changes in Mater LJT

  Class II

  FDA 510(k) K840788 Active Cleared 24 Apr 1984

• TidalPort-AP Implantable Apheresis Vascular Access Port

  Class II

  FDA 510(k) K192291 Active Cleared 20 Aug 2020

• Vascular-Access-Port LJT

  Class II

  FDA 510(k) K830000 Active Cleared 1 Mar 1983

• Norfolk Omega Port-LP Subcutaneous Implanted

  Class II

  FDA 510(k) K942784 Active Cleared 2 May 1995

See all devices from Norfolk Medical Products, Inc. →

• What is the primary purpose of the Vascular-Access Port Change Catheter LJT, and where is it typically used?

  The Vascular-Access Port Change Catheter LJT is designed for catheter exchange procedures in patients with existing subcutaneous vascular access ports. It allows clinicians to replace the catheter while keeping the port’s subcutaneous placement intact, ensuring continued secure vascular access. This device is intended for use in general hospital settings, particularly for patients requiring repeated intravascular access.

• Is the Vascular-Access Port Change Catheter LJT meant for single-use or reusable applications, and how should it be handled?

  The device is supplied as a single-use, sterile product, meaning it should only be used once per patient. Sterility is maintained through standard sterile medical device protocols, so it must be handled with aseptic techniques—opening the packaging only in a sterile field and discarding any unused portions after the procedure.

• Does this catheter come in multiple sizes or models, and if so, how would I identify the correct one for my patient?

  The data provided does not specify individual sizes or models beyond the LJT designation, which is part of Norfolk Medical’s broader vascular access family. Selection should be based on the patient’s anatomy, existing port system compatibility, and clinical guidelines. Consult the manufacturer’s product documentation or a vascular access specialist to confirm the appropriate LJT variant for your procedure.

• What regulatory pathway does the Vascular-Access Port Change Catheter LJT follow, and how does that affect its use?

  The device is regulated under the FDA 510(k) clearance process (K841150) and classified as a Class II medical device. This means it has undergone premarket review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and performance standards for subcutaneous, implanted, intravascular use. Clinicians should confirm compliance with the manufacturer’s instructions for use and institutional protocols.

• Are there any special storage requirements for the Vascular-Access Port Change Catheter LJT before use?

  Like all sterile medical devices, the catheter must be stored in its original, unopened packaging in a clean, dry environment protected from contamination. Exposure to extreme temperatures, moisture, or direct sunlight should be avoided. Follow the manufacturer’s storage guidelines to preserve sterility until immediate preoperative use.