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the crosser 14 otw catheter model cru014
Flowcardia
Summary: The Crosser 14 OTW Catheter by Flowcardia is a medical device used for crossing chronic total occlusions in peripheral arteries. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K091254 ↗
Decision Date
May 29, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Crosser 14 OTW Catheter was cleared through the FDA 510(k) pathway on May 29, 2009. Manufactured by Flowcardia, it is a Class 2 device under product code DQY.
What It Is
The Crosser 14 OTW Catheter is designed to facilitate the crossing of chronic total occlusions in peripheral arteries. It operates by using high-frequency mechanical vibrations to penetrate tough occlusions. This device is particularly useful in cases where traditional guidewire techniques are unsuccessful, providing an alternative method for revascularization.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology settings, particularly during procedures aimed at restoring blood flow in patients with peripheral artery disease. It is suitable for use in hospital catheterization labs and specialized vascular centers. The device is often employed in patients with complex occlusions that are resistant to standard guidewire techniques.
Indications for Use
The Crosser 14 OTW Catheter is indicated for use in patients with peripheral artery disease who have chronic total occlusions. It is specifically designed to assist in crossing these blockages to facilitate further treatment.
Practical Considerations
The Crosser 14 OTW Catheter is typically compatible with standard guidewire systems and can be used in conjunction with other interventional devices. Clinicians should be familiar with the catheter's operation and ensure proper sizing and technique to maximize efficacy and safety during procedures.
Frequently Asked Questions
What is the Crosser 14 OTW Catheter used for?
It is used for crossing chronic total occlusions in peripheral arteries, particularly when standard guidewire techniques are ineffective.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients with peripheral artery disease to assist in crossing chronic total occlusions.
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.