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clearway rx nb catheter
Atrium Medical
Summary: The Clearway RX NB Catheter by Atrium Medical is a Class 2 medical device used primarily in interventional cardiology for venous stenting procedures. It is utilized by cardiologists and interventional radiologists to treat vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K113112 ↗
Decision Date
November 17, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Clearway RX NB Catheter received FDA clearance through the 510(k) pathway on November 17, 2011. Manufactured by Atrium Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Clearway RX NB Catheter is a specialized catheter designed for use in vascular interventions, particularly for delivering therapeutic agents directly to the site of a vascular lesion. Its design facilitates the targeted delivery of drugs or other therapeutic substances, which can help improve outcomes in procedures such as angioplasty or stent placement.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology settings, particularly in procedures involving venous stenting. It is suitable for patients with vascular diseases requiring targeted therapy delivery. The device is often employed in hospital catheterization labs and specialized vascular centers.
Indications for Use
The FDA indications suggest that the Clearway RX NB Catheter is intended for use in patients who require venous stenting, particularly where direct delivery of therapeutic agents can enhance the treatment of vascular lesions.
Practical Considerations
The Clearway RX NB Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheterization equipment, and clinicians should be familiar with its handling and deployment techniques to ensure optimal results.
Frequently Asked Questions
What is Clearway RX NB Catheter used for?
It is used for delivering therapeutic agents directly to vascular lesions during venous stenting procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular intervention procedures.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures where direct therapeutic delivery is beneficial.
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.