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bridgepoint medical crossboss catheter model m-2000
Bridgepoint Medical
Summary: The Bridgepoint Medical CrossBoss Catheter is a device used in interventional cardiology for crossing chronic total occlusions (CTOs) in coronary arteries. It is primarily used by interventional cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K091841 ↗
Decision Date
September 2, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Bridgepoint Medical CrossBoss Catheter was cleared through the FDA 510(k) pathway on September 2, 2009. It is manufactured by Bridgepoint Medical and classified as a Class 2 device under product code DQY.
What It Is
The Bridgepoint Medical CrossBoss Catheter is a specialized catheter designed to facilitate the crossing of chronic total occlusions in coronary arteries. It features a blunt, rounded tip that can be rotated to navigate through occluded vessels. This device is particularly useful in complex percutaneous coronary interventions (PCIs) where traditional guidewires may fail to cross the lesion.
Clinical Applications
The CrossBoss Catheter is commonly used in interventional cardiology, specifically in procedures involving chronic total occlusions (CTOs) of coronary arteries. It is utilized in catheterization laboratories by interventional cardiologists to improve success rates in crossing challenging lesions. The device is particularly beneficial for patients with coronary artery disease where CTOs are present, often in older adults or those with a history of coronary interventions.
Indications for Use
The FDA-cleared indications for the CrossBoss Catheter involve its use in crossing chronic total occlusions in coronary arteries. It is intended for patients with coronary artery disease who have blockages that are difficult to treat with standard guidewires.
Practical Considerations
The CrossBoss Catheter is typically compatible with standard guide catheters and is used in conjunction with other interventional tools. Clinicians should be familiar with rotational techniques to effectively use the device. Proper sizing and selection of accompanying devices are crucial for successful outcomes.
Frequently Asked Questions
What is the Bridgepoint Medical CrossBoss Catheter used for?
It is used for crossing chronic total occlusions in coronary arteries during interventional cardiology procedures.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in crossing chronic total occlusions in coronary arteries, aiding in the treatment of 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.