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introducer set model adelante-s series
Oscor
Summary: The Adelante-S Series Introducer Set by Oscor is a medical device used primarily for vascular access in interventional procedures. It is commonly used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K122084 ↗
Decision Date
August 29, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante-S Series Introducer Set was cleared through the FDA 510k pathway on August 29, 2012. It is manufactured by Oscor and classified as a Class 2 device under product code DYB.
What It Is
The Adelante-S Series Introducer Set is a medical device designed to facilitate the introduction of catheters and other devices into the vascular system. It typically consists of a sheath and dilator, allowing for smooth insertion and minimizing trauma to the vessel. This device is crucial in procedures requiring vascular access, providing a stable and secure entry point.
Clinical Applications
This introducer set is commonly used in interventional cardiology and radiology for procedures such as angiography, stent placement, and embolization. It is suitable for use in both hospital and outpatient settings. The device is particularly useful in patients requiring repeated vascular access or those undergoing complex interventions.
Indications for Use
The FDA indications for the Adelante-S Series Introducer Set involve its use in facilitating the insertion of catheters and other devices into the vascular system. It is intended for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
Clinicians should consider the appropriate size of the introducer set based on the patient's vessel size and the procedure requirements. Compatibility with other devices, such as catheters and guidewires, should be verified to ensure seamless integration during procedures.
Frequently Asked Questions
What is the Adelante-S Series Introducer Set used for?
It is used for vascular access to facilitate the introduction of catheters and other devices during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters and other devices into the vascular system for diagnostic or therapeutic 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.