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the guider coronary guiding catheter
Intec Medical
Summary: The Guider Coronary Guiding Catheter by Intec Medical 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
K903216 ↗
Decision Date
October 19, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guider Coronary Guiding Catheter was cleared through the FDA 510(k) pathway on October 19, 1990. Manufactured by Intec Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Guider Coronary Guiding Catheter is a specialized catheter designed to facilitate the delivery of interventional devices to the coronary arteries. It provides support and stability for the passage of other instruments, such as balloon catheters or stents, during procedures like angioplasty. Its design typically includes a flexible shaft and a shaped tip to navigate the vascular anatomy efficiently.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly during percutaneous coronary interventions (PCI) to treat coronary artery disease. It is utilized in hospital settings, often in catheterization labs, by cardiologists. The device is essential for procedures involving patients with narrowed or blocked coronary arteries, aiding in the placement of stents or balloons.
Indications for Use
The catheter is indicated for use in patients requiring coronary angioplasty or stenting. It is specifically designed to help guide other devices to the site of a coronary artery blockage or narrowing, facilitating treatment.
Practical Considerations
Clinicians should consider the catheter's compatibility with other interventional devices and the specific anatomical needs of the patient. Typical sizing may vary, and selection should be based on the patient's vascular anatomy and the specifics of the procedure. Proper technique in insertion and navigation is crucial for effective use.
Frequently Asked Questions
What is the Guider Coronary Guiding Catheter used for?
It is used to guide interventional devices to the coronary arteries during procedures like angioplasty.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for guiding devices during coronary angioplasty or stenting 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.