đź“‹ FDA Reference
modification to introducer sets model adelante and adelante-s
Oscor
Summary: The Adelante and Adelante-S introducer sets by Oscor are medical devices used to facilitate the insertion of catheters and other devices into the vascular system. They are primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K090114 ↗
Decision Date
June 4, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Adelante introducer sets by Oscor were cleared through the FDA 510(k) pathway on June 4, 2009. They are classified as Class 2 devices under product code DYB.
What It Is
The Adelante and Adelante-S are introducer sets designed to aid in the insertion of catheters and other medical devices into the vascular system. These introducers typically consist of a sheath and dilator, allowing for smooth and controlled access to blood vessels. They are essential in procedures requiring vascular access, providing a stable and secure entry point.
Clinical Applications
These introducer sets are commonly used in interventional cardiology and radiology for procedures such as angiography, embolization, and other catheter-based interventions. They are suitable for use in hospital settings, particularly in catheterization labs and interventional suites. The devices are used in adult and pediatric populations requiring vascular access for diagnostic or therapeutic procedures.
Indications for Use
The FDA-cleared indications for the Adelante introducer sets include facilitating the introduction of catheters and other devices into the vascular system. They are used in patients needing vascular access for various diagnostic and interventional 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 devices used in vascular interventions. Proper technique is crucial to ensure successful insertion and minimize complications such as vessel trauma.
Frequently Asked Questions
What is the Adelante introducer set used for?
The Adelante introducer set is used to facilitate the insertion of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction 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.