Subcutaneously Implanted Drug Delivery Depot
by Norfolk Medical Products, Inc. 2 variants
510(k) K870519
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870519 | Date15 Apr 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- Withdrawn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 Subcutaneously Implanted Drug Delivery Depot is a subcutaneous port designed for vascular access, classified as a Port & Catheter, Implanted, Subcutaneous. It provides a reservoir for repeated administration of fluids or medications and facilitates blood sampling by offering a consistent, accessible needle insertion site under the skin.
This device is implanted under sterile conditions for single-use and is intended for use in general hospital settings. It is regulated under FDA 510(k) clearance (K870519) and falls under regulation number 880.5965, with a product code of LJT. The device is non-magnetic and not intended for MRI use. Storage and handling must comply with sterile medical device protocols.
From the manufacturer
INTRODUCTION The NorPortTM is a subcutaneously implanted medical device designed for use when repeated access to the vascular system is the therapy of choice. This device provides the user with an easily located needle insertion point for use whenever introducing fluids or medications into the vascular system or for acquiring periodic blood samples.
Other devices from Norfolk Medical Products, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the NorPort Subcutaneously Implanted Drug Delivery Depot primarily used for in clinical settings?
The NorPort Subcutaneously Implanted Drug Delivery Depot is designed as a subcutaneous port for vascular access, providing a reservoir under the skin to repeatedly administer fluids or medications. It also allows for consistent blood sampling by offering a stable needle insertion site, making it ideal for long-term therapy in general hospital settings.
Is this device intended for reuse, or is it meant to be used only once after implantation?
The NorPort Subcutaneously Implanted Drug Delivery Depot is explicitly intended for single-use only after implantation. It must be implanted under sterile conditions, and reuse is not supported or recommended by the manufacturer.
Can this device be used in MRI environments, or are there any safety concerns related to magnetic fields?
The NorPort Subcutaneously Implanted Drug Delivery Depot is explicitly non-magnetic and not intended for MRI use. Patients should avoid MRI procedures to prevent potential risks associated with magnetic fields.
How should the NorPort Subcutaneously Implanted Drug Delivery Depot be stored and handled to maintain sterility?
Since the device is implanted under sterile conditions and intended for single-use, storage and handling must follow sterile medical device protocols to ensure integrity. The manufacturer does not specify packaging details, but standard sterile device storage practices (e.g., sealed, dry, protected from contamination) should be applied.
What regulatory pathway does this device follow, and how is it classified by the FDA?
The NorPort Subcutaneously Implanted Drug Delivery Depot is classified under FDA 510(k) clearance (K870519) and falls under Class II medical devices (as indicated by the `device_class=2` in the regulatory data). It is regulated under FDA regulation number 880.5965 and has a product code of LJT, confirming its status as a Port & Catheter, Implanted, Subcutaneous device.