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cordis powerflex extreme pta balloon catheter cordis powerflex plus pta balloon catheter cordis powerflex p3 pta
Cordis Europa
Summary: The Cordis Powerflex PTA Balloon Catheters are used for percutaneous transluminal angioplasty (PTA) to treat vascular stenosis. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K032737 ↗
Decision Date
October 2, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis Powerflex PTA Balloon Catheters were cleared through the FDA 510(k) pathway on October 2, 2003. Manufactured by Cordis Europa, they are classified as Class 2 devices under product code DQY.
What It Is
The Cordis Powerflex PTA Balloon Catheters are medical devices designed for percutaneous transluminal angioplasty (PTA), a procedure to dilate narrowed or obstructed blood vessels. These catheters feature a balloon that can be inflated to widen the vessel, improving blood flow. They are typically used in the peripheral vascular system to treat conditions such as peripheral artery disease (PAD).
Clinical Applications
These catheters are commonly used in interventional radiology and vascular surgery settings for procedures involving the dilation of peripheral arteries. They are particularly useful in treating patients with peripheral artery disease, where they help restore adequate blood flow to the affected limbs. The devices are suitable for use in both hospital and outpatient settings, catering to adult patients with vascular stenosis.
Indications for Use
The FDA indications for these devices include use in percutaneous transluminal angioplasty to treat vascular stenosis. This means they are intended for patients with narrowed blood vessels, often due to plaque buildup, to help restore normal blood flow.
Practical Considerations
The Cordis Powerflex PTA Balloon Catheters come in various sizes to accommodate different vessel diameters and lesion lengths. They are compatible with standard guidewires and sheaths used in vascular procedures. Clinicians should be familiar with the inflation technique and pressure limits to ensure safe and effective use.
Frequently Asked Questions
What is Cordis Powerflex PTA Balloon Catheters used for?
They are used for percutaneous transluminal angioplasty to treat vascular stenosis, improving blood flow in narrowed or blocked vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these devices in their procedures.
What are the FDA-cleared indications?
They are indicated for use in percutaneous transluminal angioplasty to treat vascular stenosis, helping to restore blood flow in narrowed vessels.
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.