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prelude pursuit splittable sheath introducer
Merit Medical Systems
Summary: The Prelude Pursuit Splittable Sheath Introducer is a medical device used primarily in vascular procedures to facilitate the introduction of catheters and other devices. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K172117 ↗
Decision Date
September 11, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Prelude Pursuit Splittable Sheath Introducer was cleared through the FDA 510(k) pathway on September 11, 2017. Manufactured by Merit Medical Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The Prelude Pursuit Splittable Sheath Introducer is a specialized device designed to provide a conduit for the insertion of catheters and other interventional tools into the vascular system. Its splittable design allows for easy removal once the procedure is complete, minimizing trauma to the vessel. This device is particularly useful in procedures requiring the introduction of embolization coils or other therapeutic agents.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise delivery of coils or other embolic materials is required. It is suitable for use in both inpatient and outpatient settings, and is often employed in patients requiring vascular access for therapeutic interventions. The device is particularly beneficial in complex cases where multiple device exchanges are anticipated.
Indications for Use
The FDA-cleared indications for the Prelude Pursuit Splittable Sheath Introducer include facilitating the insertion of devices into the vascular system. It is intended for use in patients undergoing procedures that require vascular access, such as embolization or other interventional therapies.
Practical Considerations
Clinicians should consider the appropriate sizing of the sheath introducer based on the patient's vascular anatomy and the size of the devices being introduced. Compatibility with other interventional tools is essential, and the splittable design aids in reducing vessel trauma during device removal.
Frequently Asked Questions
What is the Prelude Pursuit Splittable Sheath Introducer used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system, particularly in procedures like embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of devices into the vascular system during 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.