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rubicon 18 support catheter
Boston Scientific
Summary: The Rubicon 18 Support Catheter is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists, to facilitate the placement of stents in venous systems.
FDA Clearance Information
Pathway
510K
Number
K122394 ↗
Decision Date
August 30, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Rubicon 18 Support Catheter was cleared through the FDA 510(k) pathway on August 30, 2012. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DQY.
What It Is
The Rubicon 18 Support Catheter is a specialized catheter designed to provide support during vascular interventions. It assists in the delivery and placement of stents within venous systems. The catheter's design allows for enhanced pushability and trackability, which are critical for navigating complex vascular anatomy.
Clinical Applications
Clinicians use the Rubicon 18 Support Catheter in procedures involving the placement of venous stents, particularly in cases of venous obstructions or stenosis. It is commonly employed in interventional radiology and cardiology settings, where precise stent placement is essential. The device is suitable for adult patients with conditions requiring venous intervention.
Indications for Use
The Rubicon 18 Support Catheter is indicated for use in patients who require venous stenting. This includes conditions such as venous stenosis or blockages where stent placement can help restore proper blood flow.
Practical Considerations
The Rubicon 18 is typically available in various lengths and diameters to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and stents, and clinicians should be familiar with its handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Rubicon 18 Support Catheter used for?
It is used to support the placement of stents in venous systems during vascular interventions.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring venous stenting, such as those with venous stenosis or blockages.
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.