Norfolk Medical NorPort Family of Ports
by Norfolk Medical Products, Inc.
510(k) K102385
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102385 | Date14 Jan 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5965
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The NorPort Family of Ports is a series of implanted subcutaneous and intravascular vascular access devices designed for repeated vascular access. These devices are categorized as Ports and Catheters under FDA classification II, enabling secure and reliable administration of medications, blood products, or other fluids over extended periods.
The NorPort Family is supplied sterile and intended for single-use implantation. Devices are MRI-conditional, allowing safe imaging under specific conditions as outlined in the manufacturer’s instructions. Multiple sizes and configurations are available to accommodate varying patient needs, and the devices are regulated under FDA 510(k) clearance (K102385) for general hospital use.
From the manufacturer
A Complete Line of Ports to meet all needs. The NorPort Vascular Access Port family meets the needs of all patients, from small to large, boasts what we believe to be the most secure, reliable attachment mechanism in the field, and comes power rated and MRI-Conditional. We are proud of our ports and of our history in the field.
From the first human implant of a vascular access port (VAP) in 1982, to the first omni-directional access port in 1991, to the dynamic TidalPort™ of today, Norfolk Medical has pioneered innovative, cost-effective access solutions.
Other devices from Norfolk Medical Products, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are the NorPort Family of Ports designed for reuse or are they intended for single-use implantation only?
The NorPort Family of Ports is explicitly stated as intended for single-use implantation. This is confirmed in the device description, which specifies that the devices are supplied sterile and meant to be implanted once, ensuring patient safety and minimizing infection risks.
What types of imaging can be safely performed with the NorPort Family of Ports, and are there any restrictions?
The NorPort Family of Ports is MRI-conditional, meaning they can be safely imaged under specific conditions outlined in the manufacturer’s instructions. However, the exact MRI parameters (e.g., field strength, sequence type) are not detailed here—clinicians should always refer to the manufacturer’s guidelines to ensure compatibility and safety during MRI procedures.
How many different sizes or configurations are available in the NorPort Family of Ports, and what determines the selection?
The NorPort Family includes multiple sizes and configurations to accommodate varying patient needs, though the exact dimensions or models are not listed in the provided data. Selection is typically based on factors like patient anatomy, vascular access requirements, and clinical preference, as the devices are designed for both subcutaneous and intravascular use.
What is the regulatory pathway for the NorPort Family of Ports, and how was its equivalence determined?
The NorPort Family of Ports follows the FDA 510(k) clearance pathway, classified under FDA classification II for Ports and Catheters. The decision was made under the Traditional 510(k) Review, with a Substantially Equivalent (SESE) determination by the Hemodynamics (HO) Advisory Committee for general hospital use. The clearance number is K102385, filed in 2010.
How should the NorPort Family of Ports be stored before implantation, and is there any special handling required?
While the data does not specify storage conditions in detail, the devices are supplied sterile, which implies they should be stored according to standard sterile medical device protocols—typically in a clean, dry environment, protected from contamination, and within the manufacturer’s recommended shelf life. Always follow the manufacturer’s instructions for unpacking and handling to maintain sterility.