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metacross rx pta balloon dilitation catheter
Kaneka
Summary: The Metacross RX PTA Balloon Dilitation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily used by interventional radiologists and vascular surgeons to treat narrowed or blocked blood vessels, particularly in venous stenting procedures.
FDA Clearance Information
Pathway
510K
Number
K150865 ↗
Decision Date
August 3, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Metacross RX PTA Balloon Dilitation Catheter was cleared through the FDA 510(k) pathway on August 3, 2015. It is manufactured by Kaneka and classified as a Class 2 medical device under product code DQY.
What It Is
The Metacross RX PTA Balloon Dilitation Catheter is designed for use in percutaneous transluminal angioplasty (PTA) procedures. It consists of a balloon at the tip of a catheter, which can be inflated to dilate narrowed or obstructed blood vessels. This device helps restore proper blood flow by compressing plaque against the vessel wall, making it a critical tool in vascular interventions.
Clinical Applications
This catheter is commonly used in procedures involving the dilation of peripheral arteries and veins, often in the context of venous stenting. It is utilized in interventional radiology and vascular surgery settings to treat patients with peripheral artery disease (PAD) or venous obstructions. The device is suitable for use in both inpatient and outpatient settings, depending on the complexity of the case.
Indications for Use
The FDA-cleared indications for the Metacross RX PTA Balloon Dilitation Catheter include its use in dilating narrowed or blocked blood vessels, particularly in the context of venous stenting. It is intended for patients with conditions such as peripheral artery disease or venous insufficiency.
Practical Considerations
Clinicians should consider the appropriate balloon size for the target vessel to ensure effective dilation. The device is compatible with standard guidewires and sheaths used in angioplasty procedures. Proper technique in balloon inflation and deflation is crucial to avoid vessel injury and ensure optimal outcomes.
Frequently Asked Questions
What is the Metacross RX PTA Balloon Dilitation Catheter used for?
It is used for dilating narrowed or blocked blood vessels during percutaneous transluminal angioplasty (PTA) procedures, often in conjunction with venous stenting.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their practices.
What are the FDA-cleared indications?
The device is indicated for use in dilating narrowed or obstructed blood vessels, particularly in venous stenting procedures.
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.