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guideliner v2 catheter
Vascular Solutions
Summary: The Guideliner V2 Catheter is a medical device used to facilitate the delivery of stents and other devices in coronary interventions. It is primarily used by interventional cardiologists.
FDA Clearance Information
Pathway 510K
Number K112082 ↗
Decision Date December 1, 2011
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Guideliner V2 Catheter was cleared through the FDA 510(k) pathway on December 1, 2011. It is manufactured by Vascular Solutions and classified as a Class 2 device under product code DQY.
What It Is
The Guideliner V2 Catheter is a guide catheter extension designed to provide additional support and access during complex coronary interventions. It allows for the delivery of stents and other therapeutic devices by extending the reach of standard guide catheters. This device is particularly useful in navigating challenging vascular anatomies.
Clinical Applications
The Guideliner V2 Catheter is commonly used in interventional cardiology, particularly in procedures involving complex coronary artery disease. It is employed in settings such as cardiac catheterization labs, where it aids in the delivery of stents and other devices to difficult-to-reach lesions. The device is especially beneficial for patients with tortuous or calcified coronary arteries.
Indications for Use
The FDA indications for the Guideliner V2 Catheter include its use in facilitating the delivery of interventional devices in coronary arteries. It is intended for patients undergoing percutaneous coronary interventions (PCI) where additional support is needed.
Practical Considerations
The Guideliner V2 Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guide catheters and requires careful handling to avoid vessel trauma. Clinicians should be familiar with its deployment technique to maximize its benefits.
Related Literature
The linked study investigated the incidence of complications associated with the use of the Guideliner V2 Catheter. It explored the impact of anatomical factors, such as right brachiocephalic arterial anatomy, on complication rates. The study also evaluated the redesign of the V3 Guideliner and its clinical outcomes. Key findings highlighted the importance of understanding patient-specific anatomy to minimize complications, though the study was limited by its retrospective nature.
Frequently Asked Questions
What is the Guideliner V2 Catheter used for?
The Guideliner V2 Catheter is used to facilitate the delivery of stents and other interventional devices in coronary artery procedures.
What specialties typically use this device?
Interventional cardiologists typically use the Guideliner V2 Catheter in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the delivery of interventional devices in coronary arteries during percutaneous coronary interventions.
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.