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prelude 7f short sheath introducer
Merit Medical Systems
Summary: The Prelude 7F Short Sheath Introducer is a medical device used to facilitate vascular access during procedures. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K122190 ↗
Decision Date
August 17, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Prelude 7F Short Sheath Introducer was cleared through the FDA 510(k) pathway on August 17, 2012. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Prelude 7F Short Sheath Introducer is a vascular access device designed to provide a conduit for catheters and other devices into the vascular system. It consists of a sheath and dilator, allowing for smooth insertion into blood vessels. This device is particularly useful in procedures requiring stable and reliable vascular access.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and the placement of embolization coils. It is suitable for use in both hospital and outpatient settings, and is often used in adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for the Prelude 7F Short Sheath Introducer include providing access to the vascular system for the introduction of diagnostic or therapeutic devices. It is intended for patients undergoing procedures that require vascular access.
Practical Considerations
The Prelude 7F Short Sheath Introducer is typically available in various lengths to accommodate different patient anatomies. It is compatible with a range of catheters and guidewires, and clinicians should ensure proper sizing and technique to minimize complications during insertion.
Frequently Asked Questions
What is the Prelude 7F Short Sheath Introducer used for?
It is used to facilitate vascular access for the introduction of diagnostic or therapeutic devices during procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for providing access to the vascular system for the introduction of diagnostic or therapeutic devices.
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.