Vascular-Access-Port LJT

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

Full name

Vascular-Access-Port

510(k) Number

K830000 ↗

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

• Norfolk Omega Port-LP Subcutaneous Implanted

  Class II

  FDA 510(k) K942784 Active Cleared 2 May 1995

• Norfolk Norport, Subcut. Implanted Drug Del. Depot

  Class II

  FDA 510(k) K870187 Active Cleared 7 May 1987

See all devices from Norfolk Medical Products, Inc. →

• What is the primary purpose of the Vascular-Access-Port LJT and how does it benefit patients during long-term treatment?

  The Vascular-Access-Port LJT is designed as a subcutaneous, implanted reservoir for intravenous medications, fluids, or blood products. It provides long-term venous access while minimizing patient discomfort and infection risk by reducing the need for repeated needle insertions into veins. This makes it ideal for patients requiring prolonged therapy, such as chemotherapy or antibiotic administration.

• Is the Vascular-Access-Port LJT reusable or intended for single-use implantation, and what does this mean for clinical workflow?

  The Vascular-Access-Port LJT is explicitly intended for single-use implantation, meaning each device is meant to be surgically placed once and remains in the patient for the duration of their treatment. This design eliminates the need for sterilization between uses and simplifies inventory management, as clinicians order devices based on patient needs rather than reuse cycles.

• How is the port compatible with other medical devices, and what considerations should clinicians keep in mind during use?

  The Vascular-Access-Port LJT is MRI-conditional, meaning it can be safely used in MRI environments under specific conditions (e.g., approved MRI protocols). It is also designed to securely attach to various catheter sizes, ensuring flexibility for different clinical setups. Clinicians should verify MRI compatibility with their facility’s protocols and ensure proper catheter sizing to avoid complications during access.

• What storage and handling requirements apply to the Vascular-Access-Port LJT before implantation?

  The device is supplied sterile and intended for use in general hospital settings. It must be stored according to manufacturer guidelines to maintain sterility, typically in a sealed, sterile packaging until ready for surgical implantation. Proper storage conditions (e.g., temperature, humidity) should be followed to preserve integrity before use.

• How was the regulatory pathway for this device determined, and what does the FDA’s 510(k) clearance indicate about its safety and effectiveness?

  The Vascular-Access-Port LJT was cleared via the FDA’s 510(k) pathway, specifically under the Traditional review process with a decision of *Substantially Equivalent* (SESE) to a predicate device. This clearance indicates that the device meets FDA standards for safety and performance, demonstrating that it is as safe and effective as legally marketed alternatives. The classification as a Class II device reflects its moderate regulatory oversight.