Port-A-Cath Vascular Access Systems

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

510(k) Number

K864446 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Phadebas Rast Allergen Discs

  Class II

  FDA 510(k) K823841 Active Cleared 12 Jan 1983

• Phadebact Strep F Test

  Class I

  FDA 510(k) K830445 Active Cleared 27 Apr 1983

• Delfia Plate Fluorometer 1232

  Class I

  FDA 510(k) K895240 Active Cleared 4 Oct 1989

• Mastercap Am 5.0/Mastercap Rm 5.0

  Class I

  FDA 510(k) K970420 Active Cleared 30 Jun 1997

• Phadebas Igg Rast Test

  Class II

  FDA 510(k) K810694 Active Cleared 23 Jul 1981

• Delfia Progesterone Kit

  Class I

  FDA 510(k) K890428 Active Cleared 23 Feb 1989

See all devices from Pharmacia, Inc. →

• What is the Port-A-Cath Vascular Access System used for?

  The Port-A-Cath Vascular Access System is designed for long-term vascular access in hospital settings. It allows repeated administration of fluids, medications, or blood sampling through a reservoir connected to an intravascular catheter. The system is implanted subcutaneously, providing a secure and sterile access point to the vascular system for ongoing medical interventions.

• How is the Port-A-Cath Vascular Access System supplied?

  The Port-A-Cath Vascular Access System is supplied as a sterile, single-use implant. This ensures that each device is ready for immediate use upon opening, adhering to strict sterile medical device protocols to maintain patient safety and prevent contamination.

• Is the Port-A-Cath Vascular Access System reusable?

  No, the Port-A-Cath Vascular Access System is intended for single-use only. Due to its sterile packaging and design, reuse is not recommended or approved, as it could compromise sterility and patient safety.

• What are the key components of the Port-A-Cath system?

  The system consists of a portal body with a resealable septum and outlet, which provides secure and sterile access, and an intravascular catheter connected to the reservoir. This setup allows for repeated vascular access without repeated needle insertions.

• How should the Port-A-Cath Vascular Access System be stored?

  The Port-A-Cath Vascular Access System must be stored according to sterile medical device protocols. This includes maintaining the sterile packaging until use and ensuring the device is kept in a clean, dry environment to prevent contamination or damage before implantation.