📋 FDA Reference
Atb All-Terrain Balloon PTA Dilatation Catheter
Summary: The ATB All-Terrain Balloon PTA Dilatation Catheter by Cook is a medical device used for percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K031766 ↗
Decision Date ?
June 26, 2003
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The ATB All-Terrain Balloon PTA Dilatation Catheter was cleared through the FDA 510(k) pathway on June 26, 2003. Manufactured by Cook, it is classified as a Class 2 medical device.
What It Is
The ATB All-Terrain Balloon PTA Dilatation Catheter is a specialized catheter designed for percutaneous transluminal angioplasty. It features a balloon that can be inflated to widen narrowed or obstructed blood vessels, improving blood flow. This device is particularly useful in treating peripheral arterial disease and other vascular conditions.
FDA-Cleared Indications
- Dilation of narrowed peripheral blood vessels during percutaneous transluminal angioplasty.
- Treatment of vascular stenosis to improve blood flow.
Clinical Applications
- Balloon angioplasty of stenotic peripheral arteries.
- Treatment of flow-limiting arterial narrowing in the legs and other peripheral vascular territories.
- Dilation of a peripheral vessel after guidewire access and angiographic confirmation of the lesion.
- Use in interventional radiology or vascular surgery procedures for patients with symptomatic peripheral arterial stenosis.
Reported off-label uses
- Off-label balloon dilation of selected venous stenoses may be performed in clinical practice, depending on the catheter's specifications and the treating physician's judgment.
- Off-label use in selected dialysis-access or central venous interventions has been described for balloon-catheter devices, but the specific device labeling and technical limitations must be reviewed before use.
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 should match the target vessel and lesion.
- It is used over a compatible guidewire and requires fluoroscopic or other appropriate imaging guidance for positioning and inflation.
- The balloon must be inflated and deflated according to the device instructions for use; excessive pressure or oversizing can injure the vessel.
- MRI safety depends on the catheter's exact configuration and whether it remains in the patient. Review current Cook labeling and institutional MRI policy before scanning.
- Contraindications and precautions include inability to cross the lesion safely, significant risk of vessel rupture or dissection, severe bleeding risk, and allergy or contraindication to required contrast media.
Procedures that use this device
Frequently Asked Questions
What is the ATB All-Terrain Balloon PTA 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 dilating narrowed blood vessels in patients with conditions like peripheral arterial 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.