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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 ?
510(k)
Number ?
K022061 ↗
Decision Date ?
September 20, 2002
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous dilation of narrowed or obstructed peripheral blood vessels.
- Use as a catheter-based device for treating peripheral vascular lesions when vessel dilation is clinically indicated.
Clinical Applications
- Balloon dilation of peripheral venous stenosis or obstruction.
- Endovascular treatment of narrowed peripheral vessels under fluoroscopic or other imaging guidance.
- Vessel preparation before or during selected peripheral venous interventions, when consistent with the device labeling and clinician judgment.
Reported off-label uses
- Balloon dilation of selected venous stenoses associated with dialysis access dysfunction.
- Adjunctive dilation of venous lesions before or after placement of a venous stent.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The available balloon diameters, lengths, catheter shaft dimensions and maximum inflation pressures depend on the specific catheter configuration; clinicians should confirm the current product labeling before use.
- The catheter is advanced through vascular access under imaging guidance, commonly through a percutaneous venous access site. Appropriate guidewire, sheath and vessel compatibility must be confirmed.
- Use requires clinicians trained in endovascular catheter techniques. Risks include vessel injury, dissection, perforation, thrombosis, embolization, bleeding and contrast-related complications.
- MRI safety is not established from the information provided in this FDA record. Check the device-specific labeling before MRI; do not assume that the catheter is MR safe or MR conditional.
- Contraindications and warnings may include inability to safely cross the lesion, unsuitable vessel size, severe vascular injury, uncontrolled bleeding risk or known sensitivity to materials or contrast media. The current instructions for use should guide patient selection.
Procedures that use this device
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.