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cordis ptca guiding catheter modification
Dow Corning Wright
Summary: The Cordis PTCA Guiding Catheter Modification is a medical device used in percutaneous coronary interventions (PCI) to guide catheters into coronary arteries. It is primarily used by interventional cardiologists.
FDA Clearance Information
Pathway
510K
Number
K913783 ↗
Decision Date
October 18, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis PTCA Guiding Catheter Modification was cleared through the FDA 510(k) pathway on October 18, 1991. It is manufactured by Dow Corning Wright and classified as a Class 2 device.
What It Is
The Cordis PTCA Guiding Catheter Modification is designed to facilitate the introduction and guidance of other catheters into the coronary arteries during percutaneous coronary interventions (PCI). It provides support and stability for the advancement of interventional devices such as guidewires and balloon catheters. This device is crucial in navigating the complex vasculature of the heart, ensuring precise delivery of therapeutic interventions.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology, particularly during procedures like angioplasty and stent placement. It is utilized in hospital settings, often in catheterization labs, to treat patients with coronary artery disease. The device is essential for accessing coronary arteries, especially in complex cases like chronic total occlusions (CTOs), where precise catheter guidance is critical.
Indications for Use
The FDA indications suggest that this device is intended for use in patients undergoing percutaneous coronary interventions. It is specifically designed to assist in the navigation and delivery of interventional tools within the coronary arteries.
Practical Considerations
Clinicians should consider the appropriate size and shape of the guiding catheter based on the patient's anatomy and the specific procedure. Compatibility with other interventional devices is crucial, and operators should be familiar with the catheter's handling characteristics to optimize procedural success.
Related Literature
The linked study explores techniques in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), focusing on retrograde-antegrade connection methods without guidewire externalization. It highlights challenges in advancing microcatheters into antegrade guide catheters, emphasizing the need for refined techniques. However, the study is limited by its focus on specific procedural nuances and may not address broader clinical outcomes.
Frequently Asked Questions
What is the Cordis PTCA Guiding Catheter Modification used for?
It is used to guide and support other catheters during percutaneous coronary interventions, particularly in accessing coronary arteries.
What specialties typically use this device?
This device is primarily used by interventional cardiologists in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in percutaneous coronary interventions to assist in the navigation and delivery of interventional tools within coronary arteries.
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.