đź“‹ FDA Reference
Echomark Csi Interface
Catheter Sciences
Summary: The Echomark CSI Interface is a medical device used for guiding catheters during procedures using ultrasound. It is primarily used by interventional radiologists and cardiologists for precise catheter placement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K910965 ↗
Decision Date ?
September 17, 1991
Product Code ?
LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class ?
Class 2
Evidence ?
0 studies
The Echomark CSI Interface was cleared through the FDA 510(k) pathway on September 17, 1991. It is manufactured by Catheter Sciences and is classified as a Class 2 device.
What It Is
The Echomark CSI Interface is a catheter system interface designed to enhance the guidance of catheters using ultrasound imaging. It integrates an ultrasound sensor into the catheter, allowing clinicians to visualize the catheter's position in real-time. This technology improves the accuracy of catheter placement by providing a visual marker on ultrasound images.
FDA-Cleared Indications
- Use as an interface associated with a catheter used in peripheral transluminal angioplasty procedures.
- Use to assist catheter positioning under imaging guidance during the labeled angioplasty application.
Clinical Applications
- Peripheral transluminal angioplasty procedures requiring catheter positioning.
- Ultrasound-guided localization of a catheter during a labeled peripheral vascular intervention.
Practical Considerations
- The FDA record classifies the device under product code LIT for peripheral transluminal angioplasty catheters; the available summary does not provide detailed device dimensions or catheter-size ranges.
- Compatibility with a specific catheter and ultrasound system should be confirmed in the manufacturer’s labeling before use.
- Ultrasound-system setup and any required calibration should follow the device and imaging-system instructions.
- MRI safety is not established by the information provided. Do not assume the interface or an attached catheter is MRI safe or MR conditional without manufacturer labeling.
- Contraindications, warnings, sterility, and single-use or reuse instructions should be taken from the current FDA-cleared labeling and manufacturer instructions.
Related Literature
The linked study, 'Principles of angioplasty guidance using ultrasound,' explored the use of ultrasound for guiding catheters during angioplasty. It highlighted the integration of an ultrasound sensor within the catheter to provide real-time positioning via a bright arrow on ultrasound images. The study demonstrated initial clinical success but noted the need for further research to validate the technology's efficacy across broader clinical settings.
Frequently Asked Questions
What is Echomark CSI Interface used for?
The Echomark CSI Interface is used for guiding catheters during procedures using ultrasound imaging, enhancing precision in catheter placement.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during procedures such as angioplasty and tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise catheter guidance, such as angioplasty or tumor ablation, using ultrasound imaging.
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.