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reusable interface cable 1 5 m prd-ifc-002
Creo Medical
Summary: The reusable interface cable 1.5m PRD-IFC-002 by Creo Medical is a Class 2 medical device used in tumor ablation procedures. It is typically utilized by interventional radiologists and oncologists.
FDA Clearance Information
Pathway
510K
Number
K242061 ↗
Decision Date
August 15, 2024
Product Code
KNS
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on August 15, 2024. It is manufactured by Creo Medical and classified as a Class 2 device under product code KNS.
What It Is
The reusable interface cable 1.5m PRD-IFC-002 is designed to connect ablation devices to their power sources or control units. It ensures reliable transmission of energy required for effective tumor ablation. The cable's design supports repeated use, making it a cost-effective option for medical facilities.
Clinical Applications
This device is commonly used in interventional oncology settings for tumor ablation procedures, such as radiofrequency or microwave ablation. It is suitable for use in both inpatient and outpatient settings, particularly in hospitals and specialized cancer treatment centers. The primary patient population includes individuals with solid tumors that are amenable to ablation therapy.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures aimed at destroying tumor tissues. It is intended for patients with tumors that are accessible for ablation, providing a minimally invasive treatment option.
Practical Considerations
The cable is typically 1.5 meters in length, ensuring adequate reach in various procedural setups. It is compatible with a range of ablation devices, but clinicians should verify compatibility with specific systems. Proper handling and maintenance are essential to ensure longevity and performance.
Frequently Asked Questions
What is the reusable interface cable 1.5m PRD-IFC-002 used for?
It is used to connect ablation devices to their power sources or control units during tumor ablation procedures.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures that aim to destroy tumor tissues through ablation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.