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lev-or dilation catheter otw
Baylis Medical
Summary: The Lev-Or Dilation Catheter OTW is a medical device used for dilation in venous stenting procedures. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K101117 ↗
Decision Date
July 16, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Lev-Or Dilation Catheter OTW was cleared through the FDA 510(k) pathway on July 16, 2010. It is manufactured by Baylis Medical and classified as a Class 2 device.
What It Is
The Lev-Or Dilation Catheter OTW is a specialized catheter designed to facilitate the dilation of vessels during venous stenting procedures. It operates over-the-wire (OTW), meaning it is guided along a wire to reach the target site. This device is crucial for ensuring proper placement and expansion of stents within venous structures.
Clinical Applications
This catheter is commonly used in interventional radiology and cardiology settings, particularly during procedures involving venous stenting. It is essential for patients requiring treatment for venous obstructions or insufficiencies. The device is used in hospital catheterization labs and specialized vascular centers.
Indications for Use
The FDA-cleared indications for the Lev-Or Dilation Catheter OTW involve its use in procedures requiring the dilation of veins, often in preparation for stent placement. It is suitable for patients with venous blockages or conditions necessitating vascular intervention.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters and is compatible with standard guidewires. Clinicians should be familiar with over-the-wire techniques and ensure proper sizing to optimize procedural outcomes.
Frequently Asked Questions
What is the Lev-Or Dilation Catheter OTW used for?
It is used for dilating veins during venous stenting procedures to facilitate stent placement.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vein dilation, often in preparation for stent placement in patients with venous obstructions.
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.