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cordis 6 french 0 062 i d ptca guiding cathter
Cordis
Summary: The Cordis 6 French PTCA Guiding Catheter is used in interventional cardiology for guiding devices during percutaneous transluminal coronary angioplasty (PTCA). It is primarily used by cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K915374 ↗
Decision Date
February 14, 1992
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis 6 French PTCA Guiding Catheter was cleared through the FDA 510(k) pathway on February 14, 1992. Manufactured by Cordis, it is classified as a Class II medical device.
What It Is
The Cordis 6 French PTCA Guiding Catheter is a medical device designed to facilitate the delivery of interventional devices to the coronary arteries during PTCA procedures. It features a 0.062-inch inner diameter, allowing for the passage of various interventional tools. The catheter's design ensures optimal support and stability within the vascular system, aiding in precise device placement.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology, particularly during PTCA procedures to treat coronary artery disease. It is utilized in catheterization labs by cardiologists to guide balloons, stents, and other devices to the site of a coronary lesion. The device is suitable for adult patients requiring coronary intervention, especially those with complex coronary anatomy.
Indications for Use
The FDA indications for this device involve its use in guiding interventional devices during PTCA procedures. It is intended for patients undergoing coronary angioplasty, a procedure to open narrowed or blocked coronary arteries.
Practical Considerations
The Cordis 6 French PTCA Guiding Catheter is typically compatible with standard interventional devices used in coronary procedures. Clinicians should ensure proper sizing and compatibility with other devices to optimize procedural success. The catheter's design allows for easy navigation through the vascular system, but care should be taken to minimize trauma to the vessel walls.
Frequently Asked Questions
What is the Cordis 6 French PTCA Guiding Catheter used for?
It is used to guide interventional devices during percutaneous transluminal coronary angioplasty (PTCA) procedures.
What specialties typically use this device?
Interventional cardiologists in catheterization labs commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in guiding devices during coronary angioplasty procedures to treat 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.