đź“‹ FDA Reference
advance 14rx rapid exchange pta balloon catheter
Cook
Summary: The Advance 14RX Rapid Exchange PTA Balloon Catheter by Cook is used for percutaneous transluminal angioplasty (PTA) procedures, primarily in venous stent placements. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K090822 ↗
Decision Date
April 27, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Advance 14RX Rapid Exchange PTA Balloon Catheter was cleared through the FDA 510(k) pathway on April 27, 2009. Manufactured by Cook, it is classified as a Class 2 device under product code DQY.
What It Is
The Advance 14RX Rapid Exchange PTA Balloon Catheter is a medical device designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. The catheter features a balloon that can be inflated to dilate the vessel, improving blood flow. Its rapid exchange design allows for easier and quicker catheter exchanges during procedures, enhancing efficiency and reducing procedural time.
Clinical Applications
This device is commonly used in procedures involving venous stents, particularly in cases of venous insufficiency or obstruction. Interventional radiologists and vascular surgeons often employ this catheter in hospital settings, where precise and efficient vessel dilation is required. It is suitable for adult patients with conditions that necessitate the widening of narrowed veins to restore adequate blood flow.
Indications for Use
The FDA indications for this device include its use in procedures to dilate narrowed or obstructed venous pathways. It is particularly useful for patients with conditions like chronic venous insufficiency or post-thrombotic syndrome, where improved venous flow is needed.
Practical Considerations
The Advance 14RX is available in various balloon sizes to accommodate different vessel diameters. Its rapid exchange feature is compatible with standard 0.014-inch guidewires, facilitating quick and efficient catheter changes. Clinicians should be aware of the balloon's rated burst pressure to avoid over-inflation during procedures.
Frequently Asked Questions
What is the Advance 14RX Rapid Exchange PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed or obstructed veins, often in conjunction with venous stent placements.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures to dilate narrowed or obstructed venous pathways, improving blood flow in conditions like venous insufficiency.
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.