đź“‹ FDA Reference
the crosser catheter model cr1100 and system electronics model fg1002-02
Flowcardia
Summary: The Crosser Catheter CR1100, manufactured by Flowcardia, is a medical device used in interventional cardiology to assist in crossing chronic total occlusions in peripheral arteries. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K062868 ↗
Decision Date
January 19, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Crosser Catheter CR1100 received FDA clearance through the 510(k) pathway on January 19, 2007. It is manufactured by Flowcardia and classified as a Class 2 device under product code DQY.
What It Is
The Crosser Catheter CR1100 is a specialized catheter designed to facilitate the crossing of chronic total occlusions (CTOs) in peripheral arteries. It works by delivering high-frequency mechanical vibrations to the occlusion, aiding in its disruption and allowing for subsequent interventions. This device is part of a system that includes the Crosser System Electronics Model FG1002-02, which powers the catheter and controls its operation.
Clinical Applications
The Crosser Catheter is commonly used in interventional cardiology and radiology settings, particularly in procedures involving peripheral artery disease where chronic total occlusions are present. It is suitable for use in patients with atherosclerotic disease who require revascularization of occluded vessels. The device is typically employed in hospital catheterization labs and specialized vascular centers.
Indications for Use
The FDA indications for the Crosser Catheter CR1100 involve its use in crossing chronic total occlusions in peripheral arteries. This means it is intended for patients with blocked arteries in the limbs, often due to atherosclerosis, where traditional guidewire techniques are insufficient.
Practical Considerations
The Crosser Catheter is available in various sizes to accommodate different vessel diameters and occlusion characteristics. It is compatible with standard guidewire systems and requires specific technique considerations to optimize its effectiveness, such as proper positioning and activation of the mechanical vibration feature.
Frequently Asked Questions
What is the Crosser Catheter CR1100 used for?
The Crosser Catheter CR1100 is used to facilitate the crossing of chronic total occlusions in peripheral arteries, aiding in revascularization procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in vascular intervention procedures.
What are the FDA-cleared indications?
The device is indicated for crossing chronic total occlusions in peripheral arteries, particularly in patients with peripheral 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.