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medtronic gciii coronary guiding catheter
Medtronics Interventional Vascular
Summary: The Medtronic GCIII Coronary Guiding Catheter is a device used in interventional cardiology for guiding other instruments into the coronary arteries. It is primarily used by cardiologists during procedures like angioplasty.
FDA Clearance Information
Pathway
510K
Number
K935738 ↗
Decision Date
May 4, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Medtronic GCIII Coronary Guiding Catheter was cleared through the FDA 510(k) process on May 4, 1994. It is manufactured by Medtronics Interventional Vascular and classified as a Class 2 device under the product code DQY.
What It Is
The Medtronic GCIII Coronary Guiding Catheter is a specialized catheter used in coronary interventions. It is designed to provide a stable conduit for the passage of other interventional devices, such as balloons and stents, into the coronary arteries. The catheter's design allows for precise navigation and support during complex coronary procedures.
Clinical Applications
This catheter is commonly used in percutaneous coronary interventions (PCI), such as angioplasty and stent placement, to treat coronary artery disease. It is utilized in hospital settings, particularly in cardiac catheterization labs, by interventional cardiologists. The device is suitable for adult patients with coronary artery blockages requiring intervention.
Indications for Use
The FDA indications for this device involve its use in guiding other interventional tools into the coronary arteries during procedures aimed at treating coronary artery disease. It is intended for patients with narrowed or blocked coronary arteries.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional cardiology equipment. Clinicians should be familiar with catheter manipulation techniques to optimize procedural success and minimize complications.
Frequently Asked Questions
What is the Medtronic GCIII Coronary Guiding Catheter used for?
It is used to guide other interventional devices into the coronary arteries during procedures like angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists primarily use this device during coronary interventions in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for guiding interventional tools into the coronary arteries 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.