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introducer sets model adelante radial
Oscor
Summary: The Adelante Radial Introducer Sets by Oscor are used to facilitate the insertion of catheters and other devices into the vascular system, primarily through the radial artery. They are typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K130633 ↗
Decision Date
February 13, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante Radial Introducer Sets were cleared through the FDA 510(k) pathway on February 13, 2014. Manufactured by Oscor, this Class 2 device is categorized under product code DYB.
What It Is
The Adelante Radial Introducer Sets are medical devices designed to aid in the insertion of catheters and other medical instruments into the vascular system via the radial artery. These introducers are crucial in minimally invasive procedures, providing a stable and secure access point for various interventions. The device typically includes a sheath and dilator, facilitating smooth entry and reducing trauma to the vessel.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Adelante Radial Introducer Sets are employed in procedures such as angiography, angioplasty, and the deployment of embolization coils. These sets are particularly useful in outpatient settings and catheterization labs, where radial access is preferred for its reduced complication rates. They are suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for the Adelante Radial Introducer Sets include facilitating the insertion of catheters into the vascular system, particularly for procedures involving embolization coils. This device is intended for patients undergoing diagnostic or therapeutic vascular interventions.
Practical Considerations
The Adelante Radial Introducer Sets come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with standard catheters and guidewires. Clinicians should be familiar with radial access techniques to optimize outcomes and minimize complications.
Frequently Asked Questions
What is Adelante Radial Introducer Sets used for?
The device is used to facilitate the insertion of catheters and other medical devices into the vascular system, primarily through the radial artery.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures such as angiography and angioplasty.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters into the vascular system, particularly for procedures involving 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.