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rubicon 14 18 and 35 support catheters
Boston Scientific
Summary: Rubicon support catheters are used in vascular procedures to facilitate the placement of guidewires and other devices. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K171913 ↗
Decision Date
July 25, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Rubicon support catheters were cleared via the FDA 510(k) pathway on July 25, 2017. Manufactured by Boston Scientific, these devices are classified as Class 2 under product code DQY.
What It Is
The Rubicon support catheters are medical devices designed to assist in the navigation and support of guidewires and other interventional tools within the vascular system. They come in different sizes, such as 14, 18, and 35, to accommodate various procedural needs. These catheters are designed to provide enhanced pushability and trackability, aiding clinicians in complex vascular interventions.
Clinical Applications
Rubicon support catheters are commonly used in procedures involving the placement of venous stents and other vascular interventions. Interventional radiologists and vascular surgeons utilize these catheters in hospital settings, particularly in cases requiring precise navigation through tortuous vascular anatomy. They are suitable for patients with conditions necessitating endovascular treatment.
Indications for Use
The FDA indications suggest that Rubicon support catheters are intended for use in facilitating the placement and exchange of guidewires and other interventional devices within the peripheral vasculature. They are particularly useful in patients requiring vascular access and intervention.
Practical Considerations
Rubicon catheters are available in various sizes to match procedural requirements. They are compatible with a range of guidewires and interventional tools. Clinicians should consider the catheter's size and flexibility when planning procedures to ensure optimal performance.
Related Literature
The linked study, 'Rare Disease Patient Registry & Natural History Study,' coordinated by Sanford, aims to gather data on rare diseases. Although specific findings are not available, such registries are crucial for understanding disease progression and treatment outcomes. The study's limitations include a lack of specific focus on the Rubicon catheters, but it highlights the importance of comprehensive data collection in rare disease management.
Frequently Asked Questions
What is Rubicon support catheters used for?
Rubicon support catheters are used to facilitate the placement and exchange of guidewires and other devices in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use Rubicon support catheters.
What are the FDA-cleared indications?
The catheters are indicated for use in facilitating the placement and exchange of guidewires and other interventional devices within the peripheral vasculature.
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.