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Vascular Solutions
Summary: The Guideliner Coast is a catheter extension device used in interventional cardiology to facilitate the delivery of stents and other devices. It is primarily used by cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K220647 ↗
Decision Date
August 18, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guideliner Coast was cleared through the FDA 510(k) pathway on August 18, 2022, by Vascular Solutions. It is classified as a Class 2 device under product code DQY.
What It Is
The Guideliner Coast is an extension catheter designed to provide additional support and reach during percutaneous coronary interventions. It allows for easier delivery of stents and other interventional devices to challenging or distal lesions. The device is available in multiple sizes to accommodate different vessel diameters and procedural needs.
Clinical Applications
This device is commonly used in interventional cardiology during procedures such as percutaneous coronary interventions (PCI) to treat complex coronary artery disease. It is particularly useful in cases where lesions are difficult to access or require additional support for device delivery. Cardiologists in catheterization labs frequently use it for patients with tortuous or calcified vessels.
Indications for Use
The Guideliner Coast is indicated for use in patients undergoing procedures that require the delivery of stents or other devices to coronary arteries. It is particularly beneficial for patients with complex coronary anatomy.
Practical Considerations
The Guideliner Coast comes in various sizes (5F, 6F, 7F, 8F) to ensure compatibility with different guide catheters and patient anatomies. Clinicians should consider vessel size and lesion complexity when selecting the appropriate size. Proper technique is essential to avoid vessel trauma during insertion and use.
Frequently Asked Questions
What is the Guideliner Coast used for?
The Guideliner Coast is used to facilitate the delivery of stents and other devices during percutaneous coronary interventions.
What specialties typically use this device?
Interventional cardiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in delivering stents and other devices to coronary arteries, especially in complex cases.
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.