📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Filtering blood during cardiopulmonary bypass
- Removing air and particulate matter from blood in the cardiopulmonary bypass circuit
Clinical Applications
- Use during coronary artery bypass grafting when cardiopulmonary bypass is required
- Use during cardiac surgery requiring extracorporeal circulation
- Filtration of blood returning to the cardiopulmonary bypass system
- Air and particulate removal as part of intraoperative blood management
Practical Considerations
- The filter must be correctly integrated into a compatible cardiopulmonary bypass or perfusion circuit.
- Clinicians should confirm the device size, connection type, priming requirements, and allowable flow rate before use.
- The filter is intended for use by trained cardiac surgical and perfusion personnel under the product labeling and institutional protocols.
- Inspect the device and circuit for leaks, air, damage, or incorrect connections before initiating bypass.
- This is an extracorporeal blood-circuit component, not an implantable device; MRI considerations generally relate to the complete perfusion setup and any attached components.
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.