📋 FDA Reference
Steerable Guiding Sheath Model Adelante Destino
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to provide vascular access and a conduit for the introduction of interventional devices.
- Intended to facilitate the delivery of therapeutic devices during intravascular procedures.
- The FDA-cleared use is for vascular access and device delivery; the specific procedure depends on the treating physician and compatible accessories.
Clinical Applications
- Delivery of embolization catheters and embolic materials during selected vascular embolization procedures.
- Access for catheter-based treatment of vascular disease when directional control is needed.
- Introduction of interventional devices into selected peripheral, visceral, pelvic, or other accessible vessels.
- Use in adult or pediatric patients when the selected sheath size and anatomy are appropriate.
Practical Considerations
- The sheath is available in different sizes and configurations; the appropriate choice depends on vessel diameter, access route, target anatomy, and the device being delivered.
- It is compatible only with interventional devices that meet the sheath's labeled inner-diameter, length, and compatibility requirements.
- The steerable tip requires controlled manipulation under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- MRI safety should be confirmed from the current manufacturer labeling for the specific model and configuration before an MRI examination; do not assume that the device is MR safe or MR conditional.
- Potential vascular-access and catheterization complications include bleeding, hematoma, vessel injury, thrombosis, dissection, infection, embolization, and contrast-related reactions. Contraindications and warnings should be reviewed in the current instructions for use.
Procedures that use this device
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.