đź“‹ FDA Reference
affinity flexible luer lock adapter with balance biosurface affinity flexible luer lock adapter with carmeda bioactive
Medtronic
Summary: The Affinity Flexible Luer Lock Adapter is a medical device used primarily in tumor ablation procedures. It is utilized by interventional radiologists and oncologists to ensure secure connections in medical tubing systems.
FDA Clearance Information
Pathway
510K
Number
K123448 ↗
Decision Date
December 13, 2012
Product Code
DTL
Device Class
Class 2
Evidence
0 studies
The Affinity Flexible Luer Lock Adapter by Medtronic was cleared through the FDA 510k pathway on December 13, 2012. It is classified as a Class 2 device under product code DTL.
What It Is
The Affinity Flexible Luer Lock Adapter is a connector used in medical tubing systems, featuring a balance biosurface and a Carmeda bioactive surface. These features help reduce the risk of clot formation and improve biocompatibility. The device is designed to provide a secure and leak-proof connection between various medical devices and tubing, which is crucial in procedures requiring precise fluid management.
Clinical Applications
This device is commonly used in tumor ablation procedures, where precise delivery of therapeutic agents is critical. It is particularly useful in interventional radiology and oncology settings, where maintaining secure connections in fluid delivery systems is essential. The device is suitable for use in both inpatient and outpatient settings, catering to adult and pediatric populations requiring tumor ablation.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring secure and reliable connections in medical tubing systems, particularly in the context of tumor ablation. It is suitable for patients undergoing interventional procedures where fluid management is critical.
Practical Considerations
The adapter is designed to be compatible with standard luer lock systems, ensuring ease of integration into existing setups. Clinicians should ensure proper technique in securing the connections to prevent leaks. The device's bioactive surface may offer additional benefits in reducing clot formation during prolonged procedures.
Frequently Asked Questions
What is the Affinity Flexible Luer Lock Adapter used for?
It is used to provide secure connections in medical tubing systems, particularly in tumor ablation procedures.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in tumor ablation and other interventional procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring secure and reliable connections in medical tubing systems, especially for tumor 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.