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intersept cardiotomy reservoir filter
Extracorporeal Medical Specialities
Summary: The Intersept Cardiotomy Reservoir Filter is a medical device used in cardiac surgery to filter blood. It is primarily used by cardiothoracic surgeons during procedures requiring cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K813205 ↗
Decision Date
January 28, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intersept Cardiotomy Reservoir Filter, manufactured by Extracorporeal Medical Specialities, was cleared via the FDA 510k pathway on January 28, 1982. It is classified as a Class III device under product code DTB.
What It Is
The Intersept Cardiotomy Reservoir Filter is a device used in cardiac surgery to filter and collect blood during cardiopulmonary bypass procedures. It works by removing particulate matter and air bubbles from the blood before it is returned to the patient's circulation. This helps to prevent embolic events and maintain hemodynamic stability during surgery.
Clinical Applications
This device is commonly used in cardiothoracic surgery settings, particularly during open-heart surgeries that require cardiopulmonary bypass. It is essential in procedures such as coronary artery bypass grafting (CABG), valve replacements, and complex congenital heart defect repairs. The device is used by surgical teams in operating rooms equipped for cardiac surgery.
Indications for Use
The FDA indications suggest that this device is intended for use in patients undergoing cardiac surgery where cardiopulmonary bypass is necessary. It is specifically designed to filter blood to prevent complications from air embolism and particulate matter.
Practical Considerations
Practical considerations include ensuring compatibility with existing cardiopulmonary bypass systems. The filter should be selected based on the specific requirements of the surgical procedure and the patient's size. Proper technique in setting up and maintaining the filter is crucial for optimal performance.
Frequently Asked Questions
What is the Intersept Cardiotomy Reservoir Filter used for?
It is used to filter blood during cardiac surgery, particularly in procedures requiring cardiopulmonary bypass.
What specialties typically use this device?
Cardiothoracic surgeons and surgical teams specializing in cardiac surgery use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiac surgeries requiring cardiopulmonary bypass to filter blood and prevent embolic events.
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.