📋 FDA Reference
Conquest 40 PTA Dilatation Catheter Atlas Gold PTA Dilatation Catheter Vida Ptv Dilatation Catheter Vida Bav Balloon Valvuloplasty Catheter
Summary: The Conquest 40, Atlas Gold, Vida PTV, and Vida BAV catheters are balloon dilatation devices used for percutaneous transluminal angioplasty (PTA) and valvuloplasty. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K212588 ↗
Decision Date ?
May 4, 2022
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
These devices were cleared through the FDA 510(k) pathway on May 4, 2022, by C.R. Bard. They are classified as Class 2 devices under product code DQY.
What It Is
The Conquest 40, Atlas Gold, Vida PTV, and Vida BAV catheters are specialized balloon dilatation catheters designed for use in PTA and valvuloplasty procedures. These devices help to open narrowed or obstructed blood vessels and heart valves, improving blood flow. They are equipped with high-pressure balloons that can be inflated to dilate the vessel or valve, facilitating treatment of vascular diseases.
FDA-Cleared Indications
- Percutaneous transluminal angioplasty (PTA) of stenotic peripheral blood vessels.
- Balloon valvuloplasty of stenotic heart valves, including applications covered by the Vida BAV catheter.
- Dilatation of lesions in peripheral vessels using an appropriately sized balloon catheter.
Clinical Applications
- Peripheral angioplasty to widen narrowed arteries or veins.
- Post-dilation of a peripheral vascular stent when additional expansion is clinically indicated.
- Balloon treatment of peripheral vascular stenosis in an interventional radiology or vascular procedure.
- Balloon valvuloplasty for selected stenotic heart-valve lesions with the applicable catheter model.
Reported off-label uses
- Balloon angioplasty of selected dialysis access stenoses when the catheter size and pressure rating are appropriate.
- Adjunctive balloon dilation during selected venous interventions, including treatment of stenosis associated with venous stenting.
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 devices are available in different balloon diameters, lengths, shaft configurations, and pressure ratings; the selected size should match the target anatomy and lesion.
- They are used with compatible guidewires, introducer sheaths, inflation devices, and imaging equipment according to the model-specific instructions for use.
- Inflation should be controlled and performed within the labeled pressure limits to reduce the risk of dissection, perforation, rupture, or other vessel injury.
- MRI safety depends on the specific catheter and whether it remains in the patient; consult the current model-specific labeling before MRI. These are typically single-use devices and are not intended for resterilization or reuse.
- Contraindications and precautions include inability to safely cross the lesion, unsuitable vessel or valve anatomy, significant bleeding risk, infection at the access site, and known contraindications to the procedure or required contrast agent.
Procedures that use this device
Frequently Asked Questions
What is Conquest 40 & Atlas Gold PTA Catheters used for?
These catheters are used for dilating narrowed blood vessels and heart valves to improve blood flow.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use these devices.
What are the FDA-cleared indications?
These devices are indicated for use in dilating narrowed blood vessels and heart valves in patients with vascular stenosis or valvular heart 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.