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intersept filtered cardiotomy reservoir with cortiva bioactive surface
Medtronic
Summary: The Intersept Filtered Cardiotomy Reservoir with Cortiva Bioactive Surface by Medtronic is used in cardiac surgery to filter and collect blood. It is primarily utilized by cardiovascular surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K170583 ↗
Decision Date
March 17, 2017
Product Code
DTN
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 17, 2017. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTN.
What It Is
The Intersept Filtered Cardiotomy Reservoir is a medical device used during cardiac surgery to collect and filter blood that is suctioned from the surgical field. It features a Cortiva Bioactive Surface that helps reduce the risk of clotting and inflammation. This device is crucial in maintaining blood quality during procedures requiring cardiopulmonary bypass.
Clinical Applications
This device is commonly used in cardiac surgeries such as coronary artery bypass grafting (CABG) and valve replacement procedures. It is typically used in operating rooms by cardiovascular surgeons and perfusionists to ensure the safe and efficient management of blood during surgery. The device is suitable for adult and pediatric patients undergoing complex cardiac procedures.
Indications for Use
The device is indicated for use in cardiac surgeries where blood needs to be collected and filtered before being returned to the patient. It is designed to reduce the risk of complications associated with blood handling during surgery.
Practical Considerations
The device is compatible with standard cardiopulmonary bypass systems. It is available in various sizes to accommodate different patient needs and surgical settings. Proper technique in setting up and managing the reservoir is crucial for optimal performance.
Frequently Asked Questions
What is the Intersept Filtered Cardiotomy Reservoir used for?
It is used to collect and filter blood during cardiac surgery, ensuring safe blood management.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists primarily use this device in cardiac surgeries.
What are the FDA-cleared indications?
It is indicated for use in cardiac surgeries to collect and filter blood, reducing complications during cardiopulmonary bypass.
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.