Subcutaneously Implanted Drug Delivery Depot
by Norfolk Medical Products, Inc. 2 variants
510(k) K871192
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871192 | Date10 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- Withdrawn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, 20 Sep 2026
This device is a Subcutaneous Implanted Port & Catheter, classified as a Class II medical device. It is designed for subcutaneous implantation to provide a reservoir for drug delivery or repeated vascular access, facilitating the administration of fluids, medications, or blood sampling without repeated needle insertion into veins.
The device is supplied sterile and intended for single-use implantation by a healthcare professional. It is intended for use in general hospital settings and has been granted FDA 510(k) clearance under the regulatory number K871192. The product code is LJT, and it adheres to regulatory standards outlined in 21 CFR 880.5965. No MRI safety information or reusable specifications are provided.
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.