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interface arterial blood filter model 44
Medical
Summary: The Interface Arterial Blood Filter Model 44 is a device used in cardiopulmonary bypass procedures to filter arterial blood. Key evidence highlights its role in maintaining blood flow and reducing embolic events during surgery.
FDA Clearance Information
Pathway
510K
Number
K862609 ↗
Decision Date
September 4, 1986
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Interface Arterial Blood Filter Model 44 was cleared via the FDA 510(k) pathway on September 4, 1986. It is manufactured by Medical and classified as a Class 2 device.
What It Is
The Interface Arterial Blood Filter Model 44 is designed to filter arterial blood during cardiopulmonary bypass procedures. It helps prevent embolic events by removing particulate matter and air bubbles from the bloodstream.
Clinical Applications
This device is commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as coronary artery bypass grafting (CABG). It is integral in maintaining hemodynamic stability and reducing the risk of stroke or other embolic complications.
Evidence Summary
The available literature includes 6 studies, encompassing various study designs such as RCTs and retrospective analyses. The studies span from 2011 to 2025, focusing on the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Interface Arterial Blood Filter Model 44 effectively reduces the incidence of embolic events during cardiopulmonary bypass. It is associated with improved patient outcomes, including reduced stroke rates and enhanced recovery times.
Safety Profile
Reported complications include potential device-related thrombosis and air embolism, although these are rare. The studies highlight the importance of proper device handling and monitoring during use to minimize risks.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device. Further research is needed to explore long-term outcomes and compare its efficacy with newer technologies.
Frequently Asked Questions
What are the clinical indications for Interface Arterial Blood Filter Model 44?
The device is indicated for use in cardiopulmonary bypass procedures to filter arterial blood and reduce embolic events.
What outcomes have been reported in clinical studies?
Studies report reduced embolic events and improved patient outcomes, such as lower stroke rates during cardiac surgeries.
What complications have been reported?
Reported complications include thrombosis and air embolism, though these are rare with proper device 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.