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viking optima guiding catheter
Guidant
Summary: The Viking Optima Guiding Catheter is a medical device used in interventional cardiology procedures to guide other instruments into the vascular system. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K012002 ↗
Decision Date
July 26, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Viking Optima Guiding Catheter received FDA clearance through the 510(k) pathway on July 26, 2001. It is manufactured by Guidant and classified as a Class 2 device.
What It Is
The Viking Optima Guiding Catheter is a specialized catheter designed to facilitate the placement of other interventional devices within the vascular system. It is typically used in procedures requiring precise navigation through blood vessels, such as angioplasty or stent placement. The catheter is engineered to provide optimal support and control during these procedures, enhancing the clinician's ability to reach target sites within the vasculature.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in procedures involving the coronary arteries. It is utilized in settings such as cardiac catheterization labs, where cardiologists perform diagnostic and therapeutic interventions. The catheter is suitable for adult patients undergoing procedures like percutaneous coronary interventions (PCI) or the placement of venous stents.
Indications for Use
The FDA-cleared indications for the Viking Optima Guiding Catheter include its use in guiding other devices through the vascular system, particularly in procedures involving venous stents. It is intended for patients requiring vascular access for interventional cardiology procedures.
Practical Considerations
The Viking Optima Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional tools and requires careful handling to ensure precise navigation within the vasculature.
Frequently Asked Questions
What is the Viking Optima Guiding Catheter used for?
It is used to guide other interventional devices into the vascular system 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?
The catheter is indicated for guiding devices through the vascular system, particularly in procedures involving venous stents.
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.