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cordis 7 french 0 072 i d ptca guiding catheter
Cordis
Summary: The Cordis 7 French 0.072 I.D. PTCA Guiding Catheter is a medical device used in percutaneous transluminal coronary angioplasty (PTCA) procedures. It is primarily used by interventional cardiologists to guide other instruments to the coronary arteries.
FDA Clearance Information
Pathway
510K
Number
K912777 ↗
Decision Date
September 20, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis 7 French PTCA Guiding Catheter was cleared through the FDA's 510(k) pathway on September 20, 1991. Manufactured by Cordis, it is classified as a Class 2 device under the product code DQY.
What It Is
The Cordis 7 French 0.072 I.D. PTCA Guiding Catheter is a specialized catheter designed to facilitate the delivery of interventional devices to the coronary arteries during PTCA procedures. It features a 7 French size, which refers to its outer diameter, and an internal diameter of 0.072 inches, allowing for the passage of various interventional tools. The catheter's design ensures optimal support and stability during procedures.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology, particularly during PTCA procedures to treat coronary artery disease. It is utilized in hospital settings, such as catheterization labs, by cardiologists to navigate through the vascular system to the coronary arteries. The device is suitable for adult patients undergoing angioplasty to restore blood flow in narrowed or blocked coronary arteries.
Indications for Use
The FDA-cleared indications for this device include its use in guiding other interventional devices to the coronary arteries during PTCA. It is intended for patients with coronary artery disease who require angioplasty to improve blood flow.
Practical Considerations
The Cordis 7 French PTCA Guiding Catheter is compatible with standard interventional tools used in coronary procedures. Clinicians should ensure proper sizing and compatibility with other devices. The catheter's design allows for precise navigation and support during complex interventions.
Frequently Asked Questions
What is the Cordis 7 French 0.072 I.D. PTCA Guiding Catheter used for?
It is used to guide interventional devices to the coronary arteries during PTCA procedures.
What specialties typically use this device?
Interventional cardiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in guiding devices to the coronary arteries during PTCA for patients with 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.