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interface arterial blood filter model 42
Medical
Summary: The Interface Arterial Blood Filter Model 42 is a device used in cardiopulmonary bypass procedures to filter blood. Key evidence highlights its role in reducing thromboembolic events during surgery.
FDA Clearance Information
Pathway
510K
Number
K862591 ↗
Decision Date
September 4, 1986
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Interface Arterial Blood Filter Model 42 was cleared via the FDA 510(k) pathway on September 4, 1986. It is manufactured by Medical and classified as a Class 2 device under product code DTM.
What It Is
The Interface Arterial Blood Filter Model 42 is designed to remove particulate matter and air emboli from the blood during cardiopulmonary bypass. It is intended for use in surgical settings to enhance patient safety by minimizing embolic events.
Clinical Applications
This device is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting and valve replacement. It is integral in maintaining blood purity and preventing complications associated with emboli.
Evidence Summary
The literature includes six studies, with a mix of retrospective and prospective designs, spanning from 2011 to 2025. These studies explore various aspects of device efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Interface Arterial Blood Filter Model 42 effectively reduces the incidence of thromboembolic events during cardiopulmonary bypass. It is associated with improved surgical outcomes and reduced postoperative complications.
Safety Profile
Reported complications include potential device-related thrombosis and air embolism, although these are rare. The studies emphasize the importance of proper device handling and usage to mitigate these risks.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device, with some relying on animal models. Further research is needed to confirm long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Interface Arterial Blood Filter Model 42?
The device is indicated for use in cardiopulmonary bypass procedures to filter blood and prevent embolic events.
What outcomes have been reported in clinical studies?
Clinical studies have reported a reduction in thromboembolic events and improved surgical outcomes with the use of this device.
What complications have been reported?
Safety data indicate rare occurrences of device-related thrombosis and air embolism, highlighting the need for careful handling.
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.