Norfolk Norport, Subcut. Implanted Drug Del. Depot
by Norfolk Medical Products, Inc.
510(k) K870187
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870187 | Date7 May 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- Withdrawn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, 20 Sep 2026
The Norfolk Norport Subcutaneous Implanted Drug Delivery Depot is a subcutaneous implanted port and catheter system designed for long-term intravenous access. It facilitates the administration of drugs, fluids, or nutrients directly into the bloodstream while minimizing patient discomfort and infection risk by reducing the need for repeated needle insertions.
This device is intended for single-use and is supplied sterile, requiring surgical implantation beneath the skin. It is classified as a Class II medical device under FDA regulations (880.5965) and has received FDA 510(k) clearance (K870187) as substantially equivalent to a predicate device. The system includes a reservoir and catheter for subcutaneous access, with no MRI safety restrictions specified. Proper storage and handling are critical to maintain sterility and functionality prior to use.
Other devices from Norfolk Medical Products, Inc.
Questions
AI-generated answers, 20 Sep 2026
Is this device reusable or intended for single-use only, and how does that affect its handling and storage requirements?
The Norfolk Norport Subcutaneous Implanted Drug Delivery Depot is explicitly designed for single-use only. This means it must remain sterile and undamaged until surgical implantation, after which it should not be reused. Proper storage—following manufacturer guidelines—is critical to preserve sterility and functionality before use, as reuse could compromise patient safety and device integrity.
What types of medical procedures or patients is this device typically used for, and how does it reduce patient discomfort?
This device is intended for long-term intravenous access, facilitating the administration of drugs, fluids, or nutrients directly into the bloodstream. It minimizes patient discomfort by reducing the need for repeated needle insertions, as the catheter is implanted beneath the skin and accessed via a port. This design lowers infection risk and improves patient comfort during prolonged therapy.
Are there any special storage or handling instructions to maintain the device’s sterility before implantation?
Yes, the device is supplied sterile and must be stored and handled carefully to maintain sterility before use. Since it is single-use, it should be kept in its original packaging until implantation, protected from contamination, moisture, or physical damage. Improper storage could compromise its integrity and safety for the patient.
Does this device have any restrictions on use with MRI machines, and if so, why?
The device does not specify MRI safety restrictions in the provided data, meaning it may or may not be MRI-compatible depending on its materials and construction. However, since it is implanted, clinicians should verify compatibility with their MRI equipment and protocols before use to avoid potential risks to the patient.