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rubicon support catheter
Boston Scientific
Summary: The Rubicon Support Catheter is a medical device used in vascular procedures to assist in the placement and support of guidewires. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K112303 ↗
Decision Date
November 9, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Rubicon Support Catheter was cleared through the FDA 510(k) pathway on November 9, 2011. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The Rubicon Support Catheter is designed to facilitate the placement and support of guidewires during vascular interventions. It features a flexible design that allows it to navigate through complex vascular anatomy. The catheter provides support and stability, making it easier to advance other devices through the vasculature.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in patients with peripheral vascular disease. Interventional radiologists and vascular surgeons use it in hospital settings to improve access to challenging vascular regions. It is suitable for adult patients requiring vascular intervention.
Indications for Use
The Rubicon Support Catheter is indicated for use in vascular procedures where support and guidance of guidewires are necessary. It is particularly useful in patients with complex vascular anatomy requiring stent placement.
Practical Considerations
The Rubicon Support Catheter is available in various sizes to accommodate different vascular anatomies. It is compatible with standard guidewires and can be used with a variety of vascular access techniques. Clinicians should be familiar with its handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Rubicon Support Catheter used for?
It is used to assist in the placement and support of guidewires during vascular interventions, particularly for stent placement.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in vascular procedures requiring support and guidance of guidewires, especially in complex vascular anatomies.
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.