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carto vizigo r 8 5f bi-directional guiding sheath d-1385-01-s d-1385-02-s d-1385-03-s
Biosense Webster
Summary: The Carto Vizigo R 8.5F is a bi-directional guiding sheath used in cardiac electrophysiology procedures. It is primarily utilized by cardiologists for catheter navigation during ablation therapies.
FDA Clearance Information
Pathway
510K
Number
K231412 ↗
Decision Date
July 10, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Carto Vizigo R 8.5F Guiding Sheath by Biosense Webster was cleared through the FDA 510k pathway on July 10, 2023. It is a Class 2 medical device under product code DYB.
What It Is
The Carto Vizigo R 8.5F is a bi-directional guiding sheath designed to facilitate the introduction and positioning of diagnostic and therapeutic catheters in the heart. Its bi-directional steering capability allows for enhanced maneuverability and precise catheter placement, which is crucial in complex cardiac procedures. The sheath is compatible with various catheter sizes and is often used in conjunction with mapping systems for real-time navigation.
Clinical Applications
This guiding sheath is commonly used in electrophysiology labs during procedures like atrial fibrillation ablation. It aids in the accurate placement of catheters within the cardiac chambers, making it essential for cardiologists performing complex ablation therapies. The device is particularly useful in patients with arrhythmias, where precise catheter navigation can significantly impact procedural success.
Indications for Use
The Carto Vizigo R 8.5F is indicated for use in patients undergoing cardiac ablation procedures. It is specifically designed to assist in the navigation and positioning of catheters within the heart, making it suitable for individuals with arrhythmias requiring catheter-based interventions.
Practical Considerations
The Carto Vizigo R 8.5F is available in various lengths to accommodate different patient anatomies. It is compatible with a wide range of catheters and mapping systems, ensuring versatility in the electrophysiology lab. Clinicians should be familiar with its steering mechanism to maximize its utility during procedures.
Frequently Asked Questions
What is the Carto Vizigo R 8.5F Guiding Sheath used for?
It is used to guide and position catheters during cardiac electrophysiology procedures, such as ablation therapies.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, commonly use this device in cardiac ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in cardiac ablation procedures to assist in catheter navigation and positioning within the heart.
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.