📊 Evidence-Based Reference
Interface Arterial Blood Filter 40
Medical
Summary: The Interface Arterial Blood Filter 40, manufactured by Medical, is used in cardiovascular procedures to filter blood. Key evidence highlights its role in reducing thrombotic deposits during heart surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823258 ↗
Decision Date ?
November 24, 1982
Product Code ?
DTM
Device Class ?
Class 2
Evidence ?
0 studies
The Interface Arterial Blood Filter 40 was cleared through the FDA 510k pathway on November 24, 1982. It is manufactured by Medical and classified as a Class 2 device under product code DTM.
What It Is
The Interface Arterial Blood Filter 40 is a medical device used to filter blood during cardiovascular procedures. It is designed to reduce thrombotic deposits and improve blood quality during surgeries such as heart valve replacement and coronary bypass operations.
FDA-Cleared Indications
- Use as an arterial blood filter during cardiovascular surgical procedures.
- Filter blood during procedures involving cardiopulmonary bypass or extracorporeal blood circulation.
- Help reduce thrombotic or particulate material in blood returned to the arterial circulation during surgery.
Clinical Applications
- Heart valve replacement procedures
- Aortocoronary bypass or coronary artery bypass procedures
- Other labeled cardiovascular surgical procedures requiring arterial blood filtration
- Use with an extracorporeal circulation or cardiopulmonary bypass circuit, according to the device labeling
Evidence Summary
The available literature includes two studies, one published in 1979 and another with an unspecified date. These studies explore the interaction of blood with foreign materials in surgical settings, focusing on thrombotic deposits.
Reported Outcomes
Published studies report that the Interface Arterial Blood Filter 40 effectively reduces thrombotic deposits in cardiovascular surgeries. In heart valve replacement procedures, the device helps manage thrombotic deposits, which can be as high as 375 Mcthr/nm2.
Safety Profile
Reported complications include thrombotic deposits in the blood-foreign material interface, particularly during heart valve replacement surgeries. The studies highlight the need for careful monitoring of thrombotic activity.
Evidence Limitations
The evidence is limited to a small number of studies with specific focus areas. Further research is needed to explore long-term outcomes and broader clinical applications of the device.
Practical Considerations
- Use only with compatible extracorporeal blood circuits, tubing, connectors, pumps, and cannulas specified by the manufacturer.
- Confirm the filter size, flow capacity, priming volume, and pressure limits before use; the designation “40” alone does not establish all device dimensions or performance specifications.
- The device is intended for single-procedure use unless the current labeling specifically states otherwise; do not reuse or reprocess it without validated instructions.
- MRI safety is not established from the available FDA record. Treat the device and any connected circuit as not evaluated for MRI until the manufacturer provides specific MR-conditional information.
- Potential considerations include blood loss, air or particulate embolism, clot formation, hemolysis, pressure buildup, leakage, and incompatibility with the extracorporeal circuit.
Frequently Asked Questions
What are the clinical indications for Interface Arterial Blood Filter 40?
The device is indicated for use in cardiovascular procedures such as heart valve replacement and aortocoronary bypass operations.
What outcomes have been reported in clinical studies?
Studies report a reduction in thrombotic deposits during heart surgeries, particularly in heart valve replacement procedures.
What complications have been reported?
Safety data indicate thrombotic deposits as a potential complication, necessitating careful monitoring during use.
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.