Norfolk Medical NorPort
by Norfolk Medical Products, Inc.
510(k) K871209
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871209 | Date24 Jun 1987 | 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- Withdrawn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 is an implanted subcutaneous vascular access port designed for repeated intravenous access. It provides secure, reliable intravenous catheterization for patients requiring long-term therapy, such as chemotherapy, parenteral nutrition, or blood draws.
The NorPort is supplied sterile and intended for single-use implantation by a healthcare professional. It is classified as a Class II medical device under FDA regulations and is MRI-conditional, allowing safe imaging under specific conditions. Available in multiple port sizes, it is stored in a sterile package and requires surgical implantation beneath the skin for 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.
Products The Norfolk Medical team is devoted to providing healthcare professionals and patients with high-quality products.
Other devices from Norfolk Medical Products, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of patients is the NorPort designed to support with long-term intravenous access?
The NorPort is designed for patients requiring repeated intravenous access over extended periods, such as those undergoing chemotherapy, parenteral nutrition, or frequent blood draws. Its subcutaneous implantation provides a secure, reliable method for accessing the vascular system without repeated needle insertions.
Is the NorPort reusable or intended for single-use after implantation?
The NorPort is explicitly intended for single-use implantation by a healthcare professional. While it is designed for repeated intravenous access once implanted, the device itself is not meant to be reused after removal.
What sizes or models of the NorPort are available, and how does this affect selection?
The NorPort is available in multiple port sizes, though the exact variations are not detailed in the provided data. The choice of size would typically depend on the patient’s anatomy, clinical needs, and the healthcare provider’s preference to ensure proper functionality and comfort.
Can the NorPort be used safely during MRI scans, and if so, under what conditions?
Yes, the NorPort is MRI-conditional, meaning it can be used safely during MRI imaging under specific conditions. However, the exact MRI parameters (e.g., field strength, sequence type) are not specified in the data, so consultation with the manufacturer or MRI facility is recommended before use.
How is the NorPort supplied, and what precautions should be taken during handling?
The NorPort is supplied sterile in a sealed package, ensuring it is ready for surgical implantation without additional sterilization. Since it is intended for single-use, sterile technique must be maintained during handling and implantation to prevent infection or contamination.