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cello balloon guide catheter 6f 950 mm and 1020 mm length
Fuji Systems
Summary: The Cello Balloon Guide Catheter is a medical device used in vascular procedures to assist in the placement of stents. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K120781 ↗
Decision Date
August 9, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
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
The Cello Balloon Guide Catheter is a flexible tube designed to facilitate the insertion and placement of stents within the vascular system. It features an inflatable balloon that can be used to temporarily occlude blood flow, providing a stable environment for stent deployment. This device is particularly useful in procedures requiring precise control and positioning within blood vessels.
Clinical Applications
This catheter is commonly used in endovascular procedures, particularly in the treatment of vascular diseases such as aneurysms or stenosis. Interventional radiologists and vascular surgeons utilize this device in hospital settings, often in catheterization labs, to improve the accuracy and safety of stent placements. It is suitable for adult patients with vascular conditions requiring stent intervention.
Indications for Use
The FDA-cleared indications for the Cello Balloon Guide Catheter include its use in procedures requiring the placement of venous stents. It is intended for patients with vascular conditions that necessitate the use of stents to maintain or restore blood flow.
Practical Considerations
The Cello Balloon Guide Catheter is available in lengths of 950 mm and 1020 mm, making it adaptable to various anatomical requirements. It is compatible with standard vascular access techniques and should be used by clinicians familiar with endovascular procedures.
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.
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.