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steerable guiding sheath model adelante destino
Oscor
Summary: The Adelante Destino is a steerable guiding sheath used in interventional cardiology and radiology for precise catheter placement. It is typically used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K120459 ↗
Decision Date
June 29, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante Destino, manufactured by Oscor, was cleared through the FDA 510(k) pathway on June 29, 2012. It is a Class 2 medical device under product code DYB.
What It Is
The Adelante Destino is a steerable guiding sheath designed to facilitate catheter navigation through the vascular system. It features a flexible, steerable tip that allows clinicians to maneuver through complex vascular pathways with precision. This device is particularly useful in procedures requiring access to difficult-to-reach areas within the cardiovascular system.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Adelante Destino is employed in procedures such as embolization, stent placement, and other catheter-based interventions. It is suitable for use in both hospital and outpatient settings, and is often utilized in adult patients with complex vascular anatomy requiring precise device placement.
Indications for Use
The FDA indications for the Adelante Destino include its use in facilitating the delivery and placement of interventional devices within the vascular system. It is indicated for patients requiring catheter-based interventions, particularly in complex or tortuous vascular pathways.
Practical Considerations
The Adelante Destino is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional devices. Clinicians should be familiar with the device's steering mechanism to optimize its use during procedures.
Frequently Asked Questions
What is Adelante Destino used for?
The Adelante Destino is used to guide catheters and other interventional devices through the vascular system, particularly in complex cases.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the Adelante Destino in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the delivery and placement of interventional devices within the vascular system.
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.