đź“‹ FDA Reference
Chocolate PTA Balloon Catheter Over the Wire Guide Wire 0 014 and 0 018
Summary: The Chocolate PTA Balloon Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to treat vascular stenosis. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111738 ↗
Decision Date ?
December 14, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Chocolate PTA Balloon Catheter received FDA clearance through the 510(k) pathway on December 14, 2011. Manufactured by Trireme Medical, it is classified as a Class 2 medical device.
What It Is
The Chocolate PTA Balloon Catheter is designed for use in percutaneous transluminal angioplasty (PTA) procedures. It features a unique constraining structure that helps maintain the balloon's shape, reducing vessel trauma and improving procedural outcomes. This device is used to dilate narrowed or obstructed blood vessels, typically in the peripheral vasculature.
FDA-Cleared Indications
- Dilation of stenotic lesions in peripheral arteries during percutaneous transluminal angioplasty.
- Treatment of peripheral arterial stenosis in vessels appropriate for the catheter's labeled diameter and length.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Endovascular treatment of peripheral artery disease involving appropriately sized lower-extremity arteries.
- Revascularization procedures intended to improve blood flow through a stenotic peripheral artery.
- Over-the-wire delivery through a compatible 0.014-inch or 0.018-inch guide wire, according to the specific catheter configuration.
Reported off-label uses
- Treatment of selected below-the-knee arterial lesions when used outside the device's specific labeled anatomy, size, or indication.
- Treatment of venous stenosis or occlusion, which is outside the usual arterial PTA labeling and should not be assumed to be cleared for this device.
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; the selected size must match the target vessel and lesion.
- Use only the guide-wire diameter and catheter configuration specified for the particular model: 0.014 inch or 0.018 inch.
- The device is advanced over a guide wire through a vascular access sheath or catheter under fluoroscopic imaging, with balloon inflation used to dilate the lesion.
- MRI safety depends on the specific device labeling and whether the catheter remains in the patient; confirm current manufacturer MRI information before scanning.
- Potential complications include vessel dissection, perforation, thrombosis, embolization, restenosis, bleeding at the access site, and adverse reactions to contrast. Contraindications and warnings in the current instructions for use should be reviewed before treatment.
Frequently Asked Questions
What is the Chocolate PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or obstructed peripheral arteries.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for dilating stenotic segments of peripheral arteries in patients with 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.