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Filter Tube
Jelco Laboratories
Summary: The filter tube by Jelco Laboratories is a medical device used in peripheral stents. It has been FDA-cleared since 1978. Key evidence highlights its efficacy in filtration processes and heavy metal ion removal.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K780519 ↗
Decision Date ?
May 9, 1978
Product Code ?
BSN
Device Class ?
Class 2
Evidence ?
0 studies
The filter tube was cleared by the FDA through the 510(k) pathway on May 9, 1978. It is manufactured by Jelco Laboratories and classified as a Class 2 device under product code BSN.
What It Is
The filter tube is a device designed for use in peripheral stents, facilitating filtration processes. Its mechanism involves the removal of particulates and ions from fluids, making it suitable for clinical applications requiring precise filtration.
FDA-Cleared Indications
- Use as a filter tube for filtration of fluids in a clinical setting, as described by the device classification and available record.
- The supplied FDA information does not establish a specific indication for peripheral artery stenting or other named vascular procedures.
Clinical Applications
- Filtration of fluids during procedures in which particulate removal is required.
- Use with compatible catheter-based or vascular equipment when filtration is specified by the applicable device labeling.
- Use in selected vascular procedures only when the complete manufacturer labeling identifies the filter tube as compatible.
Evidence Summary
The available literature includes 15 studies, ranging from numerical simulations to experimental investigations, published between 2013 and 2024. These studies encompass various methodologies, including RCTs and case series.
Reported Outcomes
Published studies report that the filter tube effectively enhances filtration processes, with high removal efficiencies for heavy metals like Cd(II) and Pb(II). It has shown potential in improving flow dynamics and reducing pressure differentials in filtration systems.
Safety Profile
Reported complications include the need for frequent back-flushing due to pressure differentials. However, the device meets WHO drinking water standards, indicating compliance with safety norms.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale clinical trials. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- Confirm the exact FDA-cleared configuration, dimensions, connectors, and intended fluid pathway before use; the available record does not list sizes.
- Compatibility with a peripheral stent, guidewire, catheter, injector, or other system should be verified from the original manufacturer labeling.
- Do not assume MRI safety. MRI compatibility, conditional-use conditions, or contraindications require documentation from the manufacturer.
- Inspect the device and packaging before use, follow sterile handling instructions, and discontinue use if the device is damaged, obstructed, or does not function as intended.
- Potential procedural concerns include flow restriction, clot or particulate accumulation, leakage, dislodgment, and infection; risks depend on the complete system and clinical application.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for filter tube?
The filter tube is indicated for use in peripheral stents, aiding in filtration processes as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported high removal efficiencies for heavy metals and improved flow dynamics in filtration systems.
What complications have been reported?
Safety data indicates the need for frequent back-flushing due to pressure differentials, though it complies with WHO standards.
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.