Vascular-Access Port Enlargement

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

510(k) Number

K841149 ↗

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 types of medical treatments is this vascular-access port specifically designed to support, and how does its enlarged reservoir benefit patients?

  This device is designed for intravenous administration, blood sampling, and long-term venous access, particularly for patients requiring chronic therapy like chemotherapy, antibiotics, or parenteral nutrition. The enlarged reservoir accommodates higher fluid volumes, allowing for repeated or prolonged infusions without frequent catheter replacements, which reduces patient discomfort and procedural risks.

• Is this port reusable, or is it intended for single-use only? How should it be stored to maintain sterility?

  The device is explicitly intended for single-use implantation by a healthcare professional. To maintain sterility, it must be stored according to the sterile packaging guidelines provided by the manufacturer, ensuring the packaging remains unopened and undamaged until use.

• Can this port be used in an MRI setting, and what precautions must be taken if so?

  Yes, this port is MRI-conditional under specific conditions as defined by the manufacturer. However, it must only be used with compatible catheters and connectors, and MRI procedures must adhere to the manufacturer’s guidelines to avoid risks such as heating or displacement.

• What sizes or models are available for this vascular-access port, and how do they accommodate different patient needs?

  The device is available in various sizes to suit different patient anatomies and clinical requirements. While exact dimensions aren’t specified here, the design emphasizes flexibility for long-term venous access, ensuring compatibility with a range of patient profiles in general hospital settings.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  This device underwent a Traditional 510(k) review through the FDA’s General Hospital (HO) Advisory Committee, with a decision of Substantially Equivalent (SESE). It is classified as Class II under FDA regulations, indicating it poses moderate risk and requires special controls beyond general controls.