đź“‹ FDA Reference
rubicon control support catheter h749394323506a1
Boston Scientific
Summary: The Rubicon Control Support Catheter is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It aids in the placement of venous stents.
FDA Clearance Information
Pathway
510K
Number
K223633 ↗
Decision Date
August 8, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Rubicon Control Support Catheter was cleared via the FDA 510k pathway on August 8, 2023, by Boston Scientific. It is a Class 2 device under product code DQY.
What It Is
The Rubicon Control Support Catheter is a specialized catheter designed to provide support and stability during vascular procedures. It is used to facilitate the placement of stents in venous systems, ensuring precise delivery and positioning. The catheter's design allows for enhanced control and maneuverability within the vascular anatomy.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving the placement of venous stents. It is particularly useful in treating conditions such as venous obstructions or insufficiencies. The catheter is employed in hospital settings, often in catheterization labs, and is used by specialists trained in endovascular techniques.
Indications for Use
The Rubicon Control Support Catheter is indicated for use in patients requiring venous stenting. It is suitable for conditions where there is a need to maintain or restore venous blood flow, such as in cases of venous stenosis or occlusion.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with endovascular techniques to optimize the use of this device.
Frequently Asked Questions
What is the Rubicon Control Support Catheter used for?
It is used to provide support and stability during the placement of venous stents in vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, such as treating venous obstructions or insufficiencies.
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.