Venture Wire Control Catheter Model Wcc
FDA Clearance Information
The Venture Wire Control Catheter was cleared via the FDA 510k pathway on August 1, 2006. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- Facilitation of guidewire placement and control during percutaneous vascular procedures.
- Use within the vascular system under fluoroscopic or other appropriate imaging guidance.
- Intended for use with compatible guidewires and catheter-based interventional procedures.
Clinical Applications
- Guidewire placement during percutaneous vascular interventions.
- Controlled guidewire navigation through tortuous or difficult vascular anatomy.
- Wire manipulation during catheter-based treatment of vascular lesions.
- Use in interventional catheterization procedures where directional control of a guidewire is needed.
Reported off-label uses
- Use in selected chronic total occlusion crossing techniques when the device and anatomy are appropriate; this may extend beyond the specific FDA-cleared labeling and should follow institutional protocols.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter is available in different sizes and configurations; the selected model must match the target vessel, access route, and compatible guidewire.
- Use requires fluoroscopic or other appropriate imaging guidance and operators trained in percutaneous vascular intervention.
- Inspect the catheter and packaging before use, and follow the manufacturer’s instructions for advancing, steering, flushing, and withdrawing the device.
- MRI safety depends on the exact device configuration and labeling; do not assume MRI compatibility without verifying the current manufacturer’s instructions.
- Potential risks are typical of percutaneous vascular catheterization and may include bleeding, infection, vessel injury, thrombosis, embolization, perforation, and inability to cross the intended lesion.
Procedures that use this device
Frequently Asked Questions
What is the Venture Wire Control Catheter used for?
It is used for precise guidewire control during interventional cardiology procedures, such as angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for facilitating the placement and control of guidewires in the vascular system during interventional procedures.