Norfolk Medical-Sportport-Family of Ports
by Norfolk Medical Products, Inc.
510(k) K112713
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112713 | Date27 Oct 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- Withdrawn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 Norfolk Medical SportPort Family of Ports is a Port & Catheter, Implanted, Subcutaneous, Intravascular, designed for vascular access. These devices provide secure, reliable infusion and withdrawal capabilities, enabling long-term intravenous therapy by connecting to major blood vessels via a subcutaneous port and catheter system.
The SportPort family is intended for single-use and is sterile upon packaging. It is MRI-conditional and available in multiple sizes and configurations to accommodate different patient needs. Authorized under FDA 510(k) clearance (K112713), these ports are supplied sterile and intended for implantation in general hospital settings under sterile conditions.
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
What types of patients or clinical settings is the SportPort Family of Ports designed for?
The SportPort Family of Ports is designed for general hospital settings and is intended for long-term intravenous therapy. It is suitable for patients requiring secure, reliable vascular access via a subcutaneous port and catheter system, connecting to major blood vessels. The device is authorized for use in clinical environments where sterile implantation procedures are standard.
Are the SportPort ports reusable or intended for single-use only?
The SportPort Family of Ports is explicitly intended for single-use only. Each device is sterile upon packaging, ensuring safety and compliance with medical standards for implanted devices. Reuse is not recommended or supported by the manufacturer.
Can the SportPort be used in MRI scans, and if so, what limitations apply?
Yes, the SportPort Family of Ports is MRI-conditional, meaning it can be used in MRI scans under specific conditions. However, the exact MRI safety parameters (e.g., maximum MRI strength, safe imaging sequences, and patient positioning) must be followed as outlined in the device’s labeling or instructions for use. Always verify compatibility with your MRI system before use.
How many different sizes or configurations are available for the SportPort Family, and what determines the selection?
The SportPort Family includes multiple sizes and configurations to accommodate diverse patient needs. The selection is based on factors like the patient’s anatomy, vascular access requirements, and clinical protocol. The manufacturer provides specific models for different applications, as referenced in the device’s technical documentation and product catalog.
What storage conditions are required for the SportPort ports before implantation?
The SportPort Family of Ports is supplied sterile and must be stored according to the manufacturer’s instructions to maintain sterility and integrity. Typically, this includes keeping the device in its original, unopened packaging in a clean, dry environment, protected from extreme temperatures, moisture, and direct sunlight until ready for use. Always refer to the labeling for precise storage guidelines.