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atb all-terrain balloon pta dilatation catheter
Cook
Summary: The ATB All-Terrain Balloon PTA Dilatation Catheter by Cook is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat vascular obstructions.
FDA Clearance Information
Pathway
510K
Number
K022552 ↗
Decision Date
September 27, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ATB All-Terrain Balloon PTA Dilatation Catheter received FDA clearance through the 510(k) pathway on September 27, 2002. Manufactured by Cook, it is classified as a Class 2 medical device under product code DQY.
What It Is
The ATB All-Terrain Balloon PTA Dilatation Catheter is a specialized catheter designed for percutaneous transluminal angioplasty (PTA). It features a balloon at its tip that can be inflated to dilate narrowed or obstructed blood vessels, improving blood flow. This device is particularly useful in treating peripheral vascular disease and is engineered to navigate challenging vascular anatomy.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat peripheral artery disease, particularly in the lower extremities. Patients with conditions such as atherosclerosis or venous stenosis may benefit from this device, which helps restore adequate blood flow in affected vessels.
Indications for Use
The FDA-cleared indications for this device include the treatment of vascular obstructions through balloon angioplasty. It is suitable for patients with peripheral artery disease who require vessel dilation to alleviate symptoms or prevent complications.
Practical Considerations
The ATB All-Terrain Balloon PTA Dilatation Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard angioplasty guidewires and requires careful handling to ensure precise placement and inflation. Clinicians should be familiar with the device's specifications to optimize procedural outcomes.
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 or obstructed blood vessels, improving blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in treating peripheral vascular conditions.
What are the FDA-cleared indications?
The device is indicated for treating vascular obstructions through balloon angioplasty, particularly 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.