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vado bi-directional steerable sheath
Kalila Medical
Summary: The Vado Bi-Directional Steerable Sheath is a medical device used to facilitate catheter access in complex vascular procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K162427 ↗
Decision Date
January 27, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Vado Bi-Directional Steerable Sheath was cleared through the FDA 510(k) pathway on January 27, 2017. It is manufactured by Kalila Medical and classified as a Class 2 device.
What It Is
The Vado Bi-Directional Steerable Sheath is a specialized catheter sheath designed to provide enhanced maneuverability and control during vascular access procedures. It features bi-directional steering capabilities, allowing clinicians to navigate complex vascular anatomy with precision. This device is particularly useful in procedures that require precise catheter placement, such as those involving embolization or other interventional techniques.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, where precise catheter navigation is crucial. It is particularly beneficial in procedures involving embolization coils, where accurate placement can significantly impact patient outcomes. The sheath's steerability makes it ideal for accessing challenging vascular pathways, often encountered in patients with complex anatomical variations.
Indications for Use
The Vado Bi-Directional Steerable Sheath is indicated for use in patients requiring vascular access for procedures involving embolization coils. It is designed to assist in the precise placement of catheters in complex vascular environments.
Practical Considerations
The sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheter systems and requires familiarity with steerable sheath techniques for optimal use. Proper training and experience in interventional procedures are recommended for clinicians using this device.
Frequently Asked Questions
What is the Vado Bi-Directional Steerable Sheath used for?
It is used to facilitate precise catheter access in complex vascular procedures, particularly those involving embolization coils.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures requiring precise vascular access.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures involving embolization coils, assisting in precise catheter placement.
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.