Norfolk Medical Peritoneal-Access Port
by Norfolk Medical Products, Inc.
510(k) K854593
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854593 | Date4 Feb 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LMQ
- Device Class
- Class III
- Advisory Committee
- Unknown
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Norfolk Medical Peritoneal-Access Port is a subcutaneous, implanted device designed for peritoneal access. Classified as a Class III medical device under the FDA’s nomenclature, it facilitates fluid administration or drainage into the peritoneal cavity, serving as a long-term access solution for peritoneal dialysis or other peritoneal procedures.
This device is supplied sterile and intended for single-use implantation. It is regulated under FDA 510(k) clearance (K854593) and falls under product code LMQ. Compatible with MRI environments, it is intended for sterile surgical implantation by trained professionals in clinical settings. Storage and handling must adhere to sterile medical device protocols.
From the manufacturer
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.
The Port with the Superior Reservoir Flushes easier and cleaner than any competitive port†. The introduction of the TidalPort™ line is the latest example of the spirit of innovation that thrives at Norfolk Medical as we continue the tradition of creating innovative, superior quality products.
Other devices from Norfolk Medical Products, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Norfolk Medical Peritoneal-Access Port used for in clinical settings?
The Norfolk Medical Peritoneal-Access Port is designed for long-term peritoneal access, allowing healthcare professionals to administer fluids or drain fluids from the peritoneal cavity. This makes it particularly useful for peritoneal dialysis procedures or other peritoneal interventions where repeated access is required over time.
Is the device compatible with MRI scans, and why does this matter?
Yes, the Norfolk Medical Peritoneal-Access Port is explicitly stated to be compatible with MRI environments. This matters because patients with implanted devices often require MRI imaging for diagnostic purposes, and compatibility ensures the device won’t interfere with the scan or pose safety risks during the procedure.
How is the device supplied, and what does this mean for its use?
The device is supplied sterile and intended for single-use implantation. This means it comes pre-sterilized to prevent infection and is meant to be used once before being implanted in a patient, reducing the risk of contamination or cross-infection during surgical procedures.
Who is responsible for implanting the device, and what precautions should be taken?
The device is intended for sterile surgical implantation by trained professionals in clinical settings. Since it is implanted under the skin, only qualified surgeons or interventional specialists should handle the procedure to ensure proper placement and minimize complications like infection or improper function.
What storage and handling guidelines should be followed for this device?
The device must be stored and handled according to sterile medical device protocols, as it is supplied sterile. This includes keeping it in its original packaging until use, avoiding contamination, and following manufacturer instructions to maintain its sterility and functionality before implantation.