A2 Detached Dual Port System

• • Terminated Z-0273-2007 FDA Unclassified (pre-2012) ·initiated 29 Sep 2006

  Catheter has separated from the infusion port body.

510(k) Number

K950212 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• A-Port Implant Vasc Access Syst Line Ext-A2 Port

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• Therex Low-Profile Port 1.5mm I.D. X 2.7mm O.D. Detached Catheter System

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• Low Profile Titanium Model Catalog #1003

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• A Port Implant Vascular Access System - Detached

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• Therex Low-Profile Port - Titanium Model

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  FDA 510(k) K942412 Active Cleared 19 Aug 1994

See all devices from Therex Corp. →

• What is the A2 Detached Dual Port System used for?

  The A2 Detached Dual Port System is designed for intravascular access in general hospital settings. Its dual-port configuration allows simultaneous infusion or withdrawal of fluids through separate access points, which helps minimize the risk of contamination or occlusion compared to single-port systems. This makes it particularly useful for patients requiring multiple treatments or monitoring simultaneously.

• How is the A2 Detached Dual Port System supplied?

  This system is supplied as a reusable medical device. It is intended for repeated use within clinical settings, provided proper cleaning, sterilization, and maintenance protocols are followed. The reusable nature ensures cost-effectiveness and reduces waste, though it requires adherence to strict infection control measures.

• What sizes are available for the A2 Detached Dual Port System?

  The A2 Detached Dual Port System is available in two primary outer diameter sizes: 1.0mm and 1.8mm polyurethane models. These variations allow for flexibility in patient-specific applications, accommodating different vascular access needs while maintaining compatibility with standard catheterization techniques.

• Is the A2 Detached Dual Port System sterile?

  The device is not explicitly described as sterile in its supplied state, but as a reusable medical device, it must undergo thorough sterilization between uses. Proper sterilization protocols (e.g., autoclaving or chemical sterilization) are critical to ensure patient safety and prevent infection. Always follow manufacturer guidelines for sterilization and maintenance.

• What regulatory pathway does the A2 Detached Dual Port System follow?

  The A2 Detached Dual Port System is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K950212. It is classified as a Class II device under product code LJT, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This classification ensures it meets established safety and effectiveness standards for subcutaneous, implanted port and catheter systems.