Norfolk Norport (Tm) -Sp (Skin Parallel)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K872838 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Norfolk Medical NorPort

  Class II

  FDA 510(k) K871209 Active Cleared 24 Jun 1987

• Norfolk Medical Peritoneal-Access Port

  Class III

  FDA 510(k) K854593 Active Cleared 4 Feb 1986

• Vascular Access Port Changes in Mater LJT

  Class II

  FDA 510(k) K840788 Active Cleared 24 Apr 1984

• TidalPort-AP Implantable Apheresis Vascular Access Port

  Class II

  FDA 510(k) K192291 Active Cleared 20 Aug 2020

• Vascular-Access-Port LJT

  Class II

  FDA 510(k) K830000 Active Cleared 1 Mar 1983

• Norfolk Omega Port-LP Subcutaneous Implanted

  Class II

  FDA 510(k) K942784 Active Cleared 2 May 1995

See all devices from Norfolk Medical Products, Inc. →

• What types of medical procedures or therapies is the Norfolk NorPort-SP designed to support with its long-term access solution?

  The Norfolk NorPort-SP is designed for intravenous catheterization to support long-term administration of intravenous therapies, blood draws, and fluid administration. Its subcutaneous, implanted design ensures secure access while minimizing patient discomfort, making it ideal for repeated or prolonged medical interventions in hospital settings.

• Is the Norfolk NorPort-SP intended for reuse after implantation, or is it meant to be used only once?

  The Norfolk NorPort-SP is explicitly intended for single-use implantation under sterile conditions. While the port itself is implanted, it is not designed for reuse, and proper sterile procedures must be followed during and after implantation to maintain safety and efficacy.

• What sizes or models of the Norfolk NorPort-SP are available, and how does this affect its use?

  The Norfolk NorPort-SP is available in multiple port sizes, though the exact variations are not detailed in the provided data. These size options likely accommodate different patient anatomies or clinical needs, such as varying catheter diameters or flow requirements. The choice of size should be based on the patient’s specific medical needs and the recommendations of the implanting surgeon.

• How should the Norfolk NorPort-SP be stored before implantation, and what are the sterility guarantees?

  The device is supplied sterile, meaning it is packaged and preserved to prevent contamination before use. Storage instructions are not explicitly detailed, but standard sterile medical device protocols—such as keeping it in its original, unopened packaging, protected from moisture, and at room temperature—should be followed. Always verify the manufacturer’s labeling for specific storage guidelines to ensure sterility is maintained until implantation.

• Can the Norfolk NorPort-SP be used in MRI environments, and if so, under what conditions?

  Yes, the Norfolk NorPort-SP is MRI-conditional as part of the NorPort family. This means it can be safely used in MRI environments under specific conditions, such as within defined MRI parameters (e.g., magnetic field strength, imaging sequences). However, the exact MRI safety guidelines should be confirmed with the manufacturer or referenced in the device’s labeling, as these conditions may vary based on the MRI system and protocol being used.