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8f launcher guide catheter
Medtronic Vascular
Summary: The 8f Launcher Guide Catheter is a medical device used primarily in interventional cardiology for guiding other instruments into the coronary arteries. It is typically used by cardiologists during procedures such as angioplasty or stent placement.
FDA Clearance Information
Pathway
510K
Number
K023402 ↗
Decision Date
November 6, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 8f Launcher Guide Catheter was cleared through the FDA 510(k) pathway on November 6, 2002. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The 8f Launcher Guide Catheter is a flexible tube designed to facilitate the introduction of interventional devices into the coronary arteries. It provides support and stability during procedures such as angioplasty, allowing for precise delivery of stents or balloons. Its design typically includes a soft tip to minimize vessel trauma and a reinforced shaft for optimal control and torque response.
Clinical Applications
This guide catheter is commonly used in cardiac catheterization labs during percutaneous coronary interventions (PCI). It is essential in procedures where coronary artery access is required, such as in the treatment of coronary artery disease. Cardiologists use it to navigate through the vascular system to reach the coronary arteries, often in patients with complex or multi-vessel disease.
Indications for Use
The FDA indications for the 8f Launcher Guide Catheter include its use in procedures requiring access to the coronary arteries. It is intended for patients undergoing interventions like angioplasty or stent placement, especially those with coronary artery disease.
Practical Considerations
The 8f size indicates the catheter's diameter, which is compatible with standard guidewires and interventional devices. Clinicians should be aware of the catheter's compatibility with the patient's vascular anatomy and the specific procedural requirements. Proper technique in catheter manipulation is crucial to avoid vessel trauma and ensure successful device delivery.
Frequently Asked Questions
What is the 8f Launcher Guide Catheter used for?
It is used to guide interventional devices into the coronary arteries during procedures like angioplasty or stent placement.
What specialties typically use this device?
Interventional cardiologists primarily use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in accessing coronary arteries during procedures such as angioplasty and stent placement in 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.