📋 FDA Reference
Centercross Catheter
Summary: The CenterCross Catheter by Roxwood Medical is a Class 2 medical device used primarily in vascular procedures to assist in crossing stenotic lesions or chronic total occlusions. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140910 ↗
Decision Date ?
November 19, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The CenterCross Catheter was cleared via the FDA 510(k) pathway on November 19, 2014. Manufactured by Roxwood Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The CenterCross Catheter is a specialized catheter designed to facilitate the crossing of stenotic lesions or chronic total occlusions in blood vessels. It features a unique design that aids in guiding wires and other devices through challenging vascular pathways. This device is particularly useful in complex interventional procedures where traditional catheters may struggle to navigate occluded or narrowed vessels.
FDA-Cleared Indications
- Facilitation of guidewire passage across stenotic lesions.
- Facilitation of guidewire passage across chronic total occlusions.
- Use during percutaneous vascular interventions where crossing a narrowed or occluded vessel is required.
Clinical Applications
- Crossing stenotic lesions during catheter-based vascular procedures.
- Crossing chronic total occlusions to facilitate guidewire and device delivery.
- Supporting endovascular treatment of complex narrowed or blocked vessels.
- Providing catheter support and directional control during percutaneous vascular intervention.
Practical Considerations
- The catheter is available in different sizes; the selected size should match the target vessel, access route and compatible guidewire.
- Use requires fluoroscopic or other appropriate imaging guidance and operators trained in catheter-based vascular procedures.
- Confirm guidewire, sheath and accessory-device compatibility before use.
- The FDA record provided does not establish MRI safety; consult the current manufacturer labeling before MRI.
- Potential contraindications and risks include unsuitable vascular anatomy, vessel injury, dissection, perforation, bleeding, thrombosis and embolization; follow the current instructions for use.
Related Literature
The linked registry study evaluated the performance and safety of Roxwood Medical catheters, including the CenterCross, in patients with stenotic lesions or chronic total occlusions. While specific findings are not detailed, the study aimed to assess the device's effectiveness in real-world clinical settings. Limitations include the lack of an available abstract and detailed results, which restricts comprehensive analysis.
Procedures that use this device
Frequently Asked Questions
What is the CenterCross Catheter used for?
It is used to assist in crossing 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 the CenterCross Catheter.
What are the FDA-cleared indications?
The device is indicated for use in patients with stenotic lesions or chronic total occlusions in 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.