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prelude short sheath introducer
Merit Medical Systems
Summary: The Prelude Short Sheath Introducer is a medical device used to facilitate vascular access during procedures. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K082063 ↗
Decision Date
October 15, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Prelude Short Sheath Introducer was cleared through the FDA 510k pathway on October 15, 2008. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Prelude Short Sheath Introducer is a vascular access device designed to provide a conduit for the introduction of catheters and other devices into the vascular system. It consists of a short sheath and dilator, enabling smooth entry into blood vessels. This device is particularly useful in minimizing trauma to the vessel during insertion and is essential in procedures requiring repeated access.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures, such as angiography, embolization, and catheter-based interventions. It is suitable for use in both hospital and outpatient settings, catering to a wide range of patient populations, including those requiring diagnostic or therapeutic vascular procedures.
Indications for Use
The Prelude Short Sheath Introducer is indicated for use in patients requiring vascular access for procedures like embolization, where precise delivery of coils or other embolic materials is necessary. It is designed to facilitate the introduction of devices into the vasculature with minimal trauma.
Practical Considerations
The Prelude Short Sheath Introducer comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the technique of sheath insertion to ensure optimal outcomes and minimize complications.
Frequently Asked Questions
What is the Prelude Short Sheath Introducer used for?
It is used to facilitate vascular access for procedures such as angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for vascular access in procedures requiring the introduction of devices into the vasculature, such as embolization.
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.