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interface cardiotomy blood filter
Medical
Summary: The interface cardiotomy blood filter is used during cardiopulmonary bypass to filter blood. It is primarily used by cardiac surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K781383 ↗
Decision Date
September 27, 1978
Product Code
JOD
Device Class
Class 2
Evidence
0 studies
The interface cardiotomy blood filter was cleared via the FDA 510(k) pathway on September 27, 1978. It is manufactured by Medical and classified as a Class 2 device.
What It Is
The interface cardiotomy blood filter is a medical device used during cardiopulmonary bypass procedures. It functions to remove air and particulate matter from blood returning to the heart-lung machine. This helps prevent embolic events and ensures the safety and efficacy of the bypass procedure. The filter is typically integrated into the perfusion circuit.
Clinical Applications
This device is commonly used in cardiac surgery, particularly during coronary artery bypass grafting and other procedures requiring cardiopulmonary bypass. It is essential in settings where blood management and filtration are critical, such as in operating rooms and specialized cardiac centers. The primary users are cardiac surgeons and perfusionists who manage the extracorporeal circulation.
Indications for Use
The FDA indications suggest this device is used to filter blood during cardiopulmonary bypass, specifically to remove air and particulates. It is indicated for patients undergoing cardiac surgery where bypass is necessary.
Practical Considerations
The device is compatible with standard cardiopulmonary bypass circuits. It is important to ensure proper integration into the perfusion setup to maximize efficiency. Clinicians should be familiar with the sizing and flow characteristics to optimize use.
Related Literature
The linked study compared systemic blood activation in open versus closed perfusion systems during cardiopulmonary bypass. It involved 30 patients undergoing coronary artery bypass grafting. The study found no significant differences in blood activation between groups, highlighting the effectiveness of the cardiotomy filter in both setups. Limitations include the small sample size and focus on a single surgical procedure.
Frequently Asked Questions
What is the interface cardiotomy blood filter used for?
It is used to filter blood during cardiopulmonary bypass, removing air and particulates to prevent embolic events.
What specialties typically use this device?
Cardiac surgery and perfusion specialties typically use this device in operating rooms during bypass procedures.
What are the FDA-cleared indications?
It is indicated for filtering blood during cardiopulmonary bypass to remove air and particulates in patients undergoing cardiac surgery.
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.