📋 FDA Reference
Boss Crossing Support Catheter
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 ?
510(k)
Number ?
K220632 ↗
Decision Date ?
June 2, 2022
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitates crossing of lesions in the venous system during an endovascular procedure.
- Provides support and guidance for the placement of venous stents.
- Used as an accessory catheter during percutaneous venous interventions.
Clinical Applications
- Supporting venous stent placement across a venous narrowing or obstruction.
- Providing catheter support and guidance during endovascular treatment of venous lesions.
- Crossing a venous lesion to help deliver another interventional device.
Practical Considerations
- Available sizes and working-length options should be matched to the target vessel, access route, lesion anatomy and planned stent system.
- The catheter is used with compatible guidewires and other endovascular devices according to the manufacturer's instructions for use.
- Operators should use fluoroscopic or other appropriate imaging guidance and avoid forceful advancement if resistance is encountered.
- The FDA record provided does not specify MRI safety labeling; MRI conditions should be confirmed in the current manufacturer's instructions for use before scanning.
- Contraindications, warnings and compatibility limits should be checked in the current labeling before use.
Procedures that use this device
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.