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interface arterial blood filter
Medical
Summary: The interface arterial blood filter by Medical is a device cleared by the FDA for clinical use. It is primarily used in procedures involving arterial blood filtration. Key evidence includes 11 studies exploring its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K813131 ↗
Decision Date
November 27, 1981
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 27, 1981, by the manufacturer Medical. It is classified as a Class 2 device under product code DTM.
What It Is
The interface arterial blood filter is designed to filter arterial blood during medical procedures. It is intended for use in clinical settings where blood filtration is necessary, such as during surgeries or other invasive procedures.
Clinical Applications
This device is commonly used in surgical settings where arterial blood filtration is required. It is particularly relevant in procedures that involve tumor ablation, where precise blood management is critical.
Evidence Summary
The available literature consists of 11 studies, including various types such as RCTs and case series. These studies span from 2011 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the interface arterial blood filter effectively manages arterial blood filtration during surgical procedures. The device has been associated with improved surgical outcomes in tumor ablation contexts.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of device-related complications. The safety profile is generally favorable based on the available evidence.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the device. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the interface arterial blood filter?
The device is indicated for use in arterial blood filtration during surgical procedures, particularly in tumor ablation contexts.
What outcomes have been reported in clinical studies?
Studies have reported effective blood filtration and improved surgical outcomes in procedures involving tumor ablation.
What complications have been reported?
Safety data from evidence indicates minimal adverse events, with a low incidence of device-related complications.
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.