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prelude snap splittable sheath introducer
Merit Medical Systems
Summary: The Prelude Snap Splittable Sheath Introducer is a medical device used to facilitate the insertion of catheters and other devices into blood vessels. It is primarily used by interventional radiologists and cardiologists during procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K143255 ↗
Decision Date
April 9, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Prelude Snap Splittable Sheath Introducer was cleared through the FDA 510(k) pathway on April 9, 2015. Manufactured by Merit Medical Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The Prelude Snap Splittable Sheath Introducer is a specialized medical device designed to aid in the insertion of catheters into blood vessels. It features a splittable design, allowing for easy removal once the catheter is in place, minimizing trauma to the vessel. This device is particularly useful in procedures requiring repeated access or the use of larger catheters.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Prelude Snap is ideal for procedures such as embolization, angiography, and the placement of embolization coils. It is suitable for both inpatient and outpatient settings, accommodating a wide range of patient populations, including those requiring minimally invasive vascular interventions.
Indications for Use
The FDA-cleared indications for this device include facilitating the introduction of catheters into the vascular system. It is particularly useful for patients undergoing procedures that require vascular access, such as embolization or angiography.
Practical Considerations
The Prelude Snap is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with standard guidewires and catheters, making it versatile for a range of procedures. Clinicians should be familiar with the splittable mechanism to ensure smooth operation and removal.
Frequently Asked Questions
What is the Prelude Snap Splittable Sheath Introducer used for?
It is used to facilitate the insertion of catheters into blood vessels during procedures like embolization and angiography.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device for vascular access during minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters into the vascular system, particularly for procedures requiring vascular access.
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.