đź“‹ FDA Reference
Interface Cardiotomy Blood Filter 50
Medical
Summary: The Interface Cardiotomy Blood Filter 50 is a medical device used to filter blood during cardiac procedures. It is primarily used by cardiac surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823259 ↗
Decision Date ?
November 24, 1982
Product Code ?
JOD
Device Class ?
Class 2
Evidence ?
0 studies
The Interface Cardiotomy Blood Filter 50 was cleared through the FDA 510k pathway on November 24, 1982. Manufactured by Medical, it is classified as a Class 2 device under product code JOD.
What It Is
The Interface Cardiotomy Blood Filter 50 is designed to filter and remove particulate matter from blood collected during cardiotomy procedures. It works by allowing blood to pass through a filter membrane, capturing debris and preventing it from re-entering the patient's circulation. This device is essential in maintaining blood purity during cardiac surgeries.
FDA-Cleared Indications
- Filtration of blood collected during cardiotomy procedures.
- Removal of particulate matter from blood before reinfusion during cardiac surgery.
- Use as part of a cardiopulmonary bypass blood-processing circuit.
Clinical Applications
- Filtering blood collected during open-heart surgery.
- Filtering blood in procedures using cardiopulmonary bypass.
- Filtering blood during heart valve repair or replacement procedures when incorporated into the bypass circuit.
- Filtering blood during coronary artery bypass grafting when incorporated into the bypass circuit.
- Removing surgical debris from cardiotomy blood before it is returned to the patient.
Practical Considerations
- The filter must be correctly sized and connected to the cardiopulmonary bypass or cardiotomy circuit by trained operating-room and perfusion personnel.
- Follow the manufacturer’s instructions for priming, flow rates, pressure limits, air removal, and monitoring for obstruction or clot formation.
- This is an extracorporeal blood-processing component; it is not implanted and is not intended for direct placement in a blood vessel.
- MRI safety depends on the specific configuration and materials. Because the device is used during surgery and may be connected to tubing or other equipment, it should not be taken into an MRI environment unless its labeling confirms compatibility.
- Use is subject to the clinical team’s assessment of circuit compatibility, blood-flow requirements, contraindications, and applicable institutional protocols.
Frequently Asked Questions
What is Interface Cardiotomy Blood Filter 50 used for?
It is used to filter and remove particulate matter from blood during cardiac surgeries, ensuring blood purity.
What specialties typically use this device?
Cardiac surgeons and perfusionists in operating rooms during cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for filtering blood during cardiac procedures to remove debris before returning blood to the patient.
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.