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medtronic r 8 2 french sherpa r super peak flow tm coronary guiding catheter
Medtronics Interventional Vascular
Summary: The Medtronic R 8 2 French Sherpa R Super Peak Flow TM Coronary Guiding Catheter is a medical device used in coronary interventions to guide other instruments to the heart. It is primarily used by interventional cardiologists.
FDA Clearance Information
Pathway
510K
Number
K950026 ↗
Decision Date
April 5, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on April 5, 1995. It is manufactured by Medtronics Interventional Vascular and is classified as a Class 2 device under product code DQY.
What It Is
The Medtronic R 8 2 French Sherpa R Super Peak Flow TM Coronary Guiding Catheter is a specialized catheter designed to facilitate the delivery of interventional devices to the coronary arteries. It is engineered to provide optimal support and flow dynamics during procedures, ensuring precise navigation and placement of therapeutic devices.
Clinical Applications
This guiding catheter is commonly used in percutaneous coronary interventions (PCI) to treat coronary artery disease. It is utilized in settings such as cardiac catheterization labs by interventional cardiologists. The device is suitable for adult patients requiring coronary stenting or angioplasty.
Indications for Use
The catheter is indicated for use in patients undergoing procedures to open narrowed or blocked coronary arteries. It assists in the placement of stents or other therapeutic devices to improve blood flow in the heart.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard PCI equipment and requires careful handling to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Medtronic R 8 2 French Sherpa R Super Peak Flow TM Coronary Guiding Catheter used for?
It is used to guide interventional devices to the coronary arteries during procedures such as angioplasty and stenting.
What specialties typically use this device?
Interventional cardiologists primarily use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in coronary interventions to facilitate the delivery of therapeutic devices to the heart.
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.