đź“‹ FDA Reference
introducer model adelante magnum
Oscor
Summary: The Adelante Magnum is an introducer sheath used in interventional procedures to facilitate the insertion of catheters and other devices. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K140917 ↗
Decision Date
July 9, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante Magnum, manufactured by Oscor, was cleared through the FDA 510(k) pathway on July 9, 2014. It is a Class 2 medical device under product code DYB.
What It Is
The Adelante Magnum is an introducer sheath designed to provide a stable and secure pathway for the insertion of catheters and other interventional devices into the vascular system. It features a hemostatic valve to minimize blood loss and is typically used in procedures requiring vascular access. Its design aims to facilitate smooth device exchanges and reduce trauma to the vessel.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, angioplasty, and the placement of stents or coils. It is suitable for use in both hospital and outpatient settings, particularly in patients requiring vascular interventions. The sheath is often utilized in patients with complex vascular anatomy or those undergoing multiple device exchanges.
Indications for Use
The Adelante Magnum is indicated for use in patients requiring vascular access for the delivery of interventional devices. It is particularly useful in procedures involving embolization coils, where precise device placement is critical.
Practical Considerations
The Adelante Magnum is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and devices, and its design includes features to enhance ease of use, such as a hydrophilic coating for smoother insertion.
Frequently Asked Questions
What is the Adelante Magnum used for?
The Adelante Magnum is used to provide vascular access for the insertion of catheters and interventional devices, particularly in procedures involving embolization coils.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use the Adelante Magnum in their procedures.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures requiring the delivery of interventional devices, such as embolization coils.
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.