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introducer sets models adelante and adelante-s
Oscor
Summary: The Adelante and Adelante-S introducer sets by Oscor are medical devices used to facilitate the placement of catheters and other devices into the vascular system. They are typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K073100 ↗
Decision Date
November 30, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante introducer sets, manufactured by Oscor, received FDA clearance via the 510(k) pathway on November 30, 2007. They are classified as Class 2 devices under product code DYB.
What It Is
The Adelante and Adelante-S introducer sets are designed to provide a stable and secure entry point for catheters and other interventional devices into the vascular system. These introducers typically consist of a sheath and a dilator, allowing for smooth insertion and minimizing trauma to the vessel. They are essential tools in procedures requiring vascular access, such as angiography or the placement of embolization coils.
Clinical Applications
These introducer sets are commonly used in interventional cardiology and radiology for procedures involving vascular access, such as angioplasty, stent placement, and embolization. They are suitable for use in hospital settings, particularly in catheterization labs and interventional radiology suites. The devices are used in a wide range of patient populations requiring minimally invasive vascular interventions.
Indications for Use
The FDA indications for the Adelante introducer sets include facilitating the insertion of catheters and other devices into the vascular system. They are intended for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The Adelante introducer sets come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with a range of catheters and guidewires. Clinicians should ensure proper technique to minimize the risk of vascular trauma and complications.
Frequently Asked Questions
What is Adelante used for?
The Adelante introducer sets are used to facilitate the insertion of catheters and other devices into the vascular system for diagnostic and therapeutic procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use these devices during procedures requiring vascular access.
What are the FDA-cleared indications?
The devices are indicated for facilitating the insertion of catheters and other devices into the vascular system.
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.