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tapered tip the guider coronary guiding catheter
Intec Medical
Summary: The Tapered Tip The Guider Coronary Guiding Catheter by Intec Medical is a medical device used in coronary interventions. It is primarily utilized by interventional cardiologists to guide other devices during procedures like angioplasty.
FDA Clearance Information
Pathway
510K
Number
K903217 ↗
Decision Date
October 19, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k 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 Tapered Tip The Guider Coronary Guiding Catheter is a specialized catheter designed to facilitate access to the coronary arteries. Its tapered tip allows for easier navigation through the vascular system, providing a stable platform for the delivery of interventional devices such as balloons and stents. The catheter's design helps in minimizing trauma to the vessel walls during insertion and manipulation.
Clinical Applications
This guiding catheter is commonly used in cardiac catheterization labs during percutaneous coronary interventions (PCI). Interventional cardiologists use it to perform procedures such as angioplasty and stent placement in patients with coronary artery disease. It is suitable for use in adult patients who require coronary revascularization, particularly in settings where precise device delivery is critical.
Indications for Use
The device is indicated for use in patients undergoing coronary interventions, such as those with coronary artery disease requiring angioplasty or stent placement. It assists in the accurate placement of therapeutic devices within the coronary arteries.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard interventional devices and requires careful handling to maintain its structural integrity during procedures. Clinicians should be familiar with catheter manipulation techniques to optimize outcomes.
Frequently Asked Questions
What is the Tapered Tip The Guider Coronary Guiding Catheter used for?
It is used to guide interventional devices during coronary procedures such as angioplasty and stent placement.
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 placement of therapeutic devices 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.