đź“‹ FDA Reference
cvsi peripheral balloon catheter cvsi inflater
Cryo Vascular Systems
Summary: The CVSI Peripheral Balloon Catheter is a medical device used for dilating peripheral blood vessels. It is primarily utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K022061 ↗
Decision Date
September 20, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CVSI Peripheral Balloon Catheter was cleared through the FDA's 510(k) pathway on September 20, 2002. Manufactured by Cryo Vascular Systems, it is classified as a Class 2 medical device.
What It Is
The CVSI Peripheral Balloon Catheter is designed to dilate narrowed or obstructed peripheral veins. It consists of a flexible catheter with an inflatable balloon at its tip, which is inserted into the vessel and inflated to open up the blockage. This device is crucial in procedures requiring precise vessel dilation to restore adequate blood flow.
Clinical Applications
This device is commonly used in procedures addressing peripheral venous stenosis or occlusions, such as those found in patients with chronic venous insufficiency or post-thrombotic syndrome. It is typically used in hospital settings, particularly in interventional radiology suites or operating rooms, and is essential for vascular surgeons and interventional radiologists treating adult patients with venous disorders.
Indications for Use
The FDA indications for the CVSI Peripheral Balloon Catheter include use in patients with peripheral venous blockages. It is intended for those requiring vessel dilation to improve blood flow in affected areas.
Practical Considerations
The catheter comes in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be skilled in endovascular techniques to effectively utilize this device, and it is often used in conjunction with imaging guidance for precise placement.
Frequently Asked Questions
What is the CVSI Peripheral Balloon Catheter used for?
It is used to dilate narrowed or obstructed peripheral veins to improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients with peripheral venous blockages requiring vessel dilation.
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.