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boss crossing support catheter
Marvao Medical Devices
Summary: The Boss Crossing Support Catheter, manufactured by Marvao Medical Devices, is used to assist in the placement of venous stents. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K220632 ↗
Decision Date
June 2, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Boss Crossing Support Catheter was cleared via the FDA's 510(k) pathway on June 2, 2022. It is manufactured by Marvao Medical Devices and classified as a Class II device under product code DQY.
What It Is
The Boss Crossing Support Catheter is a medical device designed to facilitate the crossing of lesions within the venous system, aiding in the placement of stents. It provides support and guidance for other interventional devices during procedures. Its design allows for enhanced maneuverability and stability, which is crucial in complex vascular interventions.
Clinical Applications
This catheter is commonly used in procedures involving the placement of venous stents, particularly in cases of chronic venous obstruction or thrombosis. Interventional radiologists and vascular surgeons often use it in hospital settings, especially in catheterization labs. It is suitable for adult patients who require venous stenting due to conditions like deep vein thrombosis or post-thrombotic syndrome.
Indications for Use
The FDA-cleared indications for the Boss Crossing Support Catheter include its use in facilitating the placement of stents in the venous system. It is intended for patients with venous blockages or narrowing that require stenting to restore proper blood flow.
Practical Considerations
The Boss Crossing Support Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and stents used in venous interventions. Clinicians should be familiar with catheter manipulation techniques to optimize procedural outcomes.
Frequently Asked Questions
What is the Boss Crossing Support Catheter used for?
It is used to assist in the placement of venous stents, particularly in complex vascular interventions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating the placement of stents in the venous system for patients with venous blockages or narrowing.
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.