Norfolk Norport/Subcutan. Implanted Drug Depot
by Norfolk Medical Products, Inc.
510(k) K863723
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863723 | Date29 Oct 1986 | 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- Withdrawn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 Norport Subcutaneous Implanted Drug Depot is a subcutaneous, implanted vascular access port designed for long-term intravenous drug administration. It provides a reservoir for repeated vascular access, facilitating continuous or intermittent infusion of medications in patients requiring sustained therapy.
This device is intended for subcutaneous implantation and is supplied sterile for single-use. It is classified as a Class II medical device under FDA regulation 880.5965 and holds an FDA 510(k) clearance (K863723) as substantially equivalent to a predicate device. The product code is LJT, and it is intended for use in general hospital settings.
From the manufacturer
INTRODUCTION Description Norfolk Medical vascular access drug delivery systems are implantable devices indicated for patient therapies requiring repeated access to the vascular system.
Other devices from Norfolk Medical Products, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Norfolk Norport Subcutaneous Implanted Drug Depot, and how does it differ from traditional intravenous access methods?
The Norfolk Norport Subcutaneous Implanted Drug Depot is designed for long-term intravenous drug administration by providing a subcutaneous reservoir for repeated vascular access. Unlike traditional intravenous methods that require frequent needle insertions, this device allows for continuous or intermittent infusion of medications through a single implanted port, reducing patient discomfort and the risk of complications from repeated punctures.
Is the Norfolk Norport device intended for reuse, or is it meant to be used only once after implantation?
The Norfolk Norport Subcutaneous Implanted Drug Depot is supplied sterile and is intended for single-use only after implantation. This ensures patient safety by preventing contamination or infection risks associated with reuse.
Where is this device typically used, and what types of medical settings are considered appropriate for its application?
The device is classified under product code LJT and is intended for use in general hospital settings. It is designed for patients requiring sustained therapy where long-term intravenous access is necessary, such as oncology, chemotherapy, or chronic medication regimens.
How is the device stored before implantation, and are there any specific handling instructions to maintain sterility?
Since the Norfolk Norport is supplied sterile, it must be stored in its original packaging until ready for use. The packaging is designed to preserve sterility, so it should remain unopened and protected from contamination until implantation. Always follow manufacturer guidelines for storage conditions to ensure integrity.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and equivalence?
The Norfolk Norport received FDA 510(k) clearance (K863723) under a Traditional 510(k) review, meaning it was determined to be substantially equivalent to a predicate device already on the market. This classification under FDA regulation 880.5965 ensures it meets established safety and performance standards for implanted vascular access ports.