📋 FDA Reference
Bard Conquest PTA Balloon Dilatation Catheter
Summary: The Bard Conquest PTA Balloon Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty. It is typically used by interventional radiologists and vascular surgeons to treat vascular stenosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K014212 ↗
Decision Date ?
January 17, 2002
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Bard Conquest PTA Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on January 17, 2002. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DQY.
What It Is
The Bard Conquest PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty (PTA), a procedure to dilate narrowed or obstructed blood vessels. The catheter features a balloon that can be inflated to open up the vessel, improving blood flow. This device is particularly useful in treating peripheral vascular disease, where blood vessels outside the heart and brain become narrowed.
FDA-Cleared Indications
- Treatment of stenotic or obstructed peripheral blood vessels by percutaneous transluminal angioplasty.
- Use in the peripheral vasculature, including vessels affected by atherosclerotic or other narrowing.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Treatment of peripheral arterial stenosis causing reduced blood flow to an extremity.
- Dilation of a vascular narrowing after guidewire access has been established.
- Use during endovascular treatment of peripheral vascular disease when balloon angioplasty is clinically appropriate.
Reported off-label uses
- Balloon angioplasty of selected venous stenoses, including lesions encountered during central or iliac venous interventions, when clinically justified.
- Adjunctive balloon dilation after venous thrombectomy or before venous stent placement.
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 multiple balloon diameters and lengths; selection should match the target vessel, lesion length, and procedural access requirements.
- It is used over a compatible guidewire through an appropriately sized introducer sheath. Confirm compatibility and usable catheter length before the procedure.
- Inflation pressure limits, preparation, and deflation technique must follow the current device labeling and instructions for use.
- MRI safety depends on the specific catheter model and whether it remains in the patient; review the current labeling before MRI. A temporary angioplasty catheter is normally removed after treatment.
- Contraindications and precautions include inability to safely cross the lesion, severe vessel tortuosity or calcification, unsuitable vessel diameter, active infection at the access site, and risks associated with vascular access, contrast, anticoagulation, and balloon angioplasty.
Procedures that use this device
Frequently Asked Questions
What is the Bard Conquest PTA Balloon Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed blood vessels and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of narrowed blood vessels, particularly in the peripheral vasculature, such as in peripheral artery disease.
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.