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cvsi peripheral balloon catheter cvsi catheter inflation unit
Cryo Vascular Systems
Summary: The CVSI Peripheral Balloon Catheter is a medical device used in vascular interventions to open narrowed or blocked blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K023463 ↗
Decision Date
February 19, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CVSI Peripheral Balloon Catheter, manufactured by Cryo Vascular Systems, was cleared by the FDA via the 510k pathway on February 19, 2003. It is classified as a Class 2 device under product code DQY.
What It Is
The CVSI Peripheral Balloon Catheter is a device designed to dilate stenotic or obstructed blood vessels in the peripheral vascular system. It consists of a catheter with an inflatable balloon at its tip, which is inserted into the vessel and inflated to compress plaque and widen the vessel lumen. This device is commonly used in procedures to improve blood flow in patients with peripheral artery disease.
Clinical Applications
This catheter is frequently used in interventional radiology and vascular surgery to treat peripheral artery disease, particularly in the lower extremities. It is suitable for use in hospital settings, outpatient surgical centers, and specialized vascular clinics. The device is typically employed in patients with atherosclerotic disease, where it helps restore adequate blood flow to affected limbs, reducing symptoms like claudication.
Indications for Use
The FDA indications for this device include the treatment of narrowed or blocked peripheral blood vessels. It is intended for patients with conditions such as peripheral artery disease, where restoring blood flow can alleviate symptoms and improve quality of life.
Practical Considerations
The CVSI Peripheral Balloon Catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and requires careful technique to ensure proper placement and inflation. Clinicians should be trained in endovascular procedures to use this device effectively.
Frequently Asked Questions
What is the CVSI Peripheral Balloon Catheter used for?
It is used to dilate narrowed or blocked peripheral blood vessels, improving blood flow in conditions like peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for the treatment of narrowed or blocked peripheral blood vessels, particularly in patients with peripheral artery disease.
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.