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steerable guiding sheath model adelante destino
Oscor
Summary: The Adelante Destino is a steerable guiding sheath used in interventional procedures to facilitate the delivery of devices. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K122960 ↗
Decision Date
December 13, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante Destino was cleared through the FDA 510(k) pathway on December 13, 2012. Manufactured by Oscor, it is classified as a Class 2 device under product code DYB.
What It Is
The Adelante Destino is a steerable guiding sheath designed to provide a conduit for the introduction of interventional devices into the vasculature. It features a flexible, steerable tip that allows for precise navigation through complex vascular anatomy. This device is particularly useful in procedures requiring enhanced control and access to target sites.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Adelante Destino facilitates procedures such as embolization, stent placement, and other catheter-based interventions. It is suitable for use in both hospital and outpatient settings, catering to adult and pediatric patient populations requiring vascular access.
Indications for Use
The FDA-cleared indications suggest that the Adelante Destino is intended for use in patients requiring vascular access for the delivery of therapeutic devices. It is particularly beneficial in complex cases where precise navigation is crucial.
Practical Considerations
The Adelante Destino comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of interventional devices and requires familiarity with steerable sheath techniques for optimal use.
Frequently Asked Questions
What is the Adelante Destino used for?
The Adelante Destino is used to guide and deliver interventional devices into the vasculature during procedures like embolization and stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use the Adelante Destino in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients needing vascular access for the delivery of therapeutic devices, especially in complex vascular procedures.
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.