Cello Balloon Guide Catheter 6f 950 Mm and 1020 Mm Length
Fuji Systems
FDA Clearance Information
The Cello Balloon Guide Catheter was cleared through the FDA 510(k) pathway on August 9, 2012. It is manufactured by Fuji Systems and classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Used as a percutaneous catheter during endovascular vascular procedures.
- Intended to provide catheter access and support for procedures involving the vascular system.
- The FDA record does not, in the information provided, establish a specific indication for venous stent placement.
Clinical Applications
- Providing vascular access during catheter-based procedures.
- Supporting endovascular treatment when temporary balloon occlusion or flow control is required by the procedure.
- Providing a conduit for the delivery of compatible endovascular devices under imaging guidance.
Reported off-label uses
- Flow arrest or proximal protection during selected venous interventions, including some thrombectomy or venous stenting procedures, when judged appropriate by the treating physician.
- Temporary flow control during selected arterial endovascular procedures.
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
- Available in 6 French sizes with shaft lengths of 950 mm and 1020 mm; the appropriate length depends on the access site, target vessel, and patient anatomy.
- The balloon should be inflated only with the recommended inflation medium and volume, using fluoroscopic or other appropriate imaging guidance and following the current instructions for use.
- Compatibility with guidewires, sheaths, and other devices must be confirmed before use; vessel diameter and access-site requirements should be assessed.
- MRI safety and conditional-use requirements are not established in the information provided. Confirm the current manufacturer labeling before an MRI examination.
- Potential complications include vascular injury, bleeding, thrombosis, embolization, dissection, perforation, infection, balloon rupture, and complications related to the access site.
Procedures that use this device
Frequently Asked Questions
What is the Cello Balloon Guide Catheter used for?
It is used to assist in the placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of venous stents to maintain or restore blood flow.