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clearway otw model 85912
Atrium Medical
Summary: The Clearway OTW Model 85912 is a medical device used primarily in interventional cardiology for delivering therapeutic agents directly to vascular sites. It is utilized by cardiologists in catheterization labs to treat vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K093431 ↗
Decision Date
April 20, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Clearway OTW Model 85912, manufactured by Atrium Medical, received FDA clearance through the 510(k) pathway on April 20, 2010. It is classified as a Class 2 device under product code DQY.
What It Is
The Clearway OTW Model 85912 is an over-the-wire catheter designed for targeted delivery of therapeutic agents to specific vascular sites. It is used to administer drugs directly to areas of arterial blockage or narrowing, enhancing the efficacy of treatment by concentrating medication at the site of need. This device is particularly useful in procedures where precise delivery of medication is critical.
Clinical Applications
Commonly used in interventional cardiology, the Clearway OTW Model 85912 is employed in procedures such as angioplasty where localized drug delivery can improve outcomes. It is suitable for use in catheterization labs, primarily by cardiologists treating patients with coronary artery disease or other vascular conditions. The device is beneficial for patients requiring targeted therapy to reduce restenosis or manage acute thrombotic events.
Indications for Use
The FDA-cleared indications for the Clearway OTW Model 85912 involve its use in delivering therapeutic agents directly to vascular sites. This is particularly indicated for patients with conditions like coronary artery disease where localized drug delivery can improve treatment efficacy.
Practical Considerations
The Clearway OTW Model 85912 is compatible with standard catheterization lab equipment and is available in various sizes to accommodate different vessel diameters. Clinicians should be familiar with over-the-wire techniques and ensure compatibility with the therapeutic agents being used.
Frequently Asked Questions
What is Clearway OTW Model 85912 used for?
It is used for the targeted delivery of therapeutic agents to specific vascular sites, particularly in interventional cardiology.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for delivering therapeutic agents directly to vascular sites, especially in patients with coronary artery disease.
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.