📋 FDA Reference
Atb All-Terrain Balloon PTA Dilatation Catheter
Summary: The ATB All-Terrain Balloon PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to dilate narrowed or obstructed blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K033875 ↗
Decision Date ?
April 2, 2004
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The ATB All-Terrain Balloon PTA Dilatation Catheter was cleared by the FDA through the 510(k) pathway on April 2, 2004. It is manufactured by Cook and classified as a Class 2 medical device under product code DQY.
What It Is
The ATB All-Terrain Balloon PTA Dilatation Catheter is designed for use in percutaneous transluminal angioplasty procedures. It features a balloon that can be inflated to dilate narrowed or blocked blood vessels, improving blood flow. This device is particularly useful in treating peripheral vascular disease and is engineered to navigate challenging vascular anatomy.
FDA-Cleared Indications
- Dilation of stenotic peripheral blood vessels during percutaneous transluminal angioplasty.
- Treatment of vascular narrowing caused by peripheral vascular disease or other obstructive lesions.
- Use in vessels that can be reached percutaneously with an appropriately sized angioplasty catheter.
Clinical Applications
- Balloon angioplasty of stenotic peripheral arteries.
- Treatment of atherosclerotic narrowing in lower-extremity arteries.
- Dilation of obstructed peripheral vascular segments after guidewire access has been established.
- Adjunctive balloon dilation during selected peripheral vascular interventions.
Reported off-label uses
- Balloon dilation of venous stenoses, including selected lesions encountered during venous interventions.
- Balloon preparation or post-dilation of a venous stent in selected cases.
- Dilation of stenoses in vascular access circuits, when the catheter size and pressure specifications are appropriate.
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 balloon diameters and lengths; selection should match the target vessel and lesion.
- It is used with compatible guidewires, introducer sheaths, inflation devices, and contrast media according to the current instructions for use.
- The balloon should be positioned and inflated under fluoroscopic imaging, with inflation pressure kept within the device's specified limits.
- MRI safety depends on the exact catheter model and whether it remains in the patient; consult the current labeling. A temporary angioplasty catheter is generally removed after treatment.
- Important risks include vessel dissection or perforation, thrombosis, embolization, bleeding at the access site, restenosis, contrast reaction, and loss of distal blood flow. Contraindications and warnings are defined in the manufacturer's current labeling.
Procedures that use this device
Frequently Asked Questions
What is the ATB All-Terrain Balloon PTA Dilatation Catheter used for?
It is used for dilating narrowed or obstructed blood vessels in percutaneous transluminal angioplasty procedures.
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 dilating stenotic segments of blood vessels, particularly in patients with peripheral vascular 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.