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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
510K
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.
Clinical Applications
This device is commonly used in heart valve replacement and aortocoronary bypass operations. It plays a crucial role in maintaining blood purity and minimizing thrombotic risks during these procedures.
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.
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.