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tubing and connectors with trillium biopassive surface
Medtronic Vascular
Summary: This device is a set of tubing and connectors with a Trillium biopassive surface, used primarily in surgical settings for tumor ablation procedures. It is utilized by surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K012538 ↗
Decision Date
August 23, 2001
Product Code
DWF
Device Class
Class 2
Evidence
0 studies
The tubing and connectors with Trillium biopassive surface were cleared through the FDA 510k pathway on August 23, 2001. Manufactured by Medtronic Vascular, this device is classified as Class 2 under product code DWF.
What It Is
This device consists of tubing and connectors coated with a Trillium biopassive surface, designed to minimize thrombogenicity and enhance biocompatibility. The Trillium coating is a polymer-based surface treatment that reduces protein adsorption and platelet activation, which is crucial during procedures requiring extracorporeal circulation. The device is engineered to ensure secure connections and reliable fluid transport in medical settings.
Clinical Applications
The tubing and connectors are commonly used in tumor ablation procedures, where maintaining a sterile and efficient fluid pathway is critical. They are particularly relevant in surgical oncology and interventional radiology, where precise fluid management is necessary. The device is suitable for use in hospitals and specialized surgical centers, catering to adult and pediatric patient populations undergoing complex procedures.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in procedures requiring reliable fluid management, particularly in tumor ablation. It is designed to support the safe and effective delivery of fluids during surgical interventions.
Practical Considerations
The tubing and connectors are typically available in various sizes to accommodate different procedural needs. Compatibility with existing surgical equipment is a key consideration, and the device is designed to integrate seamlessly with standard oxygenators and fluid management systems. Proper technique in securing connections is essential to ensure optimal performance.
Related Literature
The linked study evaluated the safety of oxygenator connections, focusing on grip strength and arterial temperature measurement accuracy. The study compared various oxygenator connectors and biopassive tubings, including the Trillium-coated tubing. Key findings highlighted the importance of secure connections for safety and efficacy, though the study was limited by its focus on specific oxygenator models and conditions.
Frequently Asked Questions
What is tubing and connectors with Trillium biopassive surface used for?
This device is used in surgical procedures requiring reliable fluid management, such as tumor ablation, to ensure safe and effective delivery of fluids.
What specialties typically use this device?
Specialties such as surgical oncology and interventional radiology commonly use this device during complex procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures that require secure and efficient fluid management, particularly in tumor ablation contexts.
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.