📋 FDA Reference
Multicross Support Catheter
Summary: The multicross support catheter by Roxwood Medical is a Class 2 medical device used in interventional cardiology for navigating through stenotic lesions or chronic total occlusions. It is primarily used by cardiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121763 ↗
Decision Date ?
November 27, 2012
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The multicross support catheter was cleared through the FDA 510k pathway on November 27, 2012. Manufactured by Roxwood Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The multicross support catheter is a specialized tool used in interventional cardiology to facilitate the crossing of stenotic lesions or chronic total occlusions in blood vessels. It is designed to provide support and stability to guidewires and other interventional devices during complex procedures. The catheter's design allows for enhanced maneuverability and access in challenging vascular anatomy.
FDA-Cleared Indications
- Use in the percutaneous treatment of stenotic lesions.
- Use in the percutaneous treatment of chronic total occlusions.
- Use to support guidewire or interventional-device advancement through difficult vascular lesions.
Clinical Applications
- Crossing narrowed blood vessels during catheter-based treatment.
- Crossing chronic total occlusions when additional catheter support is needed.
- Providing support and stability for guidewires during endovascular procedures.
- Facilitating delivery of compatible interventional devices to a target vascular lesion.
Practical Considerations
- Available sizes, working lengths, and vessel compatibility depend on the specific catheter configuration; clinicians should verify the current manufacturer specifications before use.
- Use only with guidewires and interventional devices compatible with the catheter's lumen and dimensions.
- Advance and withdraw the catheter under appropriate fluoroscopic or other imaging guidance; do not force it through resistance.
- The record provided does not establish MRI safety. MRI conditions should be confirmed in the current device labeling before scanning a patient with the catheter in place.
- Contraindications, warnings, and anticoagulation or procedural requirements should be reviewed in the current instructions for use.
Related Literature
The linked registry study evaluated the performance and safety of Roxwood Medical catheters in patients with stenotic lesions or chronic total occlusions. Although specific details and findings are not available, such studies typically assess the device's success in crossing occlusions and its safety profile. Limitations may include the lack of a control group or long-term follow-up data.
Procedures that use this device
Frequently Asked Questions
What is the multicross support catheter used for?
It is used to facilitate the crossing of stenotic lesions or chronic total occlusions in blood vessels during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in patients with stenotic lesions or chronic total occlusions, meaning narrowed or blocked blood vessels.
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.