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Centercross Ultra Lv Catheter
Summary: The CenterCross Ultra LV Catheter is a medical device used to facilitate the placement of guidewires in complex vascular procedures. It is primarily utilized by interventional cardiologists and radiologists in the treatment of venous stenosis and chronic total occlusions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K170403 ↗
Decision Date ?
March 7, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The CenterCross Ultra LV Catheter was cleared through the FDA 510(k) pathway on March 7, 2017. It is manufactured by Roxwood Medical and classified as a Class 2 device under product code DQY.
What It Is
The CenterCross Ultra LV Catheter is a specialized catheter designed to aid in the navigation and placement of guidewires across stenotic lesions or chronic total occlusions in the vasculature. It features a unique design that allows for enhanced control and precision during complex interventions. This device is particularly useful in cases where traditional guidewire techniques are challenging.
FDA-Cleared Indications
- Percutaneous use to facilitate the placement and navigation of guidewires within the vasculature.
- Use during endovascular treatment of vascular stenotic lesions.
- Use during endovascular treatment of chronic total occlusions.
- Use in conjunction with compatible guidewires and other interventional devices.
Clinical Applications
- Supporting guidewire crossing of a difficult vascular stenosis.
- Supporting guidewire navigation through a chronic total occlusion.
- Providing catheter support during percutaneous endovascular interventions.
- Helping establish access for subsequent vascular treatment when guidewire positioning is challenging.
Practical Considerations
- The catheter is available in different configurations and sizes; selection should match the target vessel, access route and compatible guidewire.
- Use requires fluoroscopic or other appropriate imaging guidance by clinicians trained in percutaneous vascular intervention.
- The catheter should be handled according to the current manufacturer instructions for use, including recommendations for guidewire compatibility, flushing and advancement.
- MRI safety depends on the specific device labeling and configuration; verify the current instructions for use before an MRI examination.
- Potential risks include vascular injury, perforation, dissection, bleeding, thrombosis, embolization, infection and device-related complications. Contraindications and warnings should be reviewed in the current labeling.
Related Literature
The linked study is a registry evaluating the performance and safety of Roxwood Medical catheters in patients with stenotic lesions or chronic total occlusions. While specific results are not available, such studies typically assess the success rate of lesion crossing and any associated complications. Limitations may include a lack of randomized control and potential selection bias.
Procedures that use this device
Frequently Asked Questions
What is the CenterCross Ultra LV Catheter used for?
It is used to facilitate the placement of guidewires across stenotic lesions or chronic total occlusions in the vasculature.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients with stenotic lesions or chronic total occlusions, aiding in the crossing of vascular blockages.
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.