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prelude guide sheath
Merit Medical Systems
Summary: The Prelude Guide Sheath is a medical device used in vascular procedures to facilitate the introduction of catheters and other devices. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K211405 ↗
Decision Date
October 4, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Prelude Guide Sheath, manufactured by Merit Medical Systems, received FDA clearance through the 510(k) pathway on October 4, 2021. It is classified as a Class 2 device.
What It Is
The Prelude Guide Sheath is a vascular access device designed to provide a stable pathway for the introduction of catheters and other interventional tools into the vascular system. It is constructed to minimize trauma to the vessel wall and facilitate smooth device exchanges. The sheath is typically used in procedures requiring precise catheter placement.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Prelude Guide Sheath is employed in procedures such as embolization, angiography, and other catheter-based interventions. It is suitable for use in both hospital and outpatient settings, aiding in the treatment of patients with vascular conditions requiring minimally invasive techniques.
Indications for Use
The FDA-cleared indications for the Prelude Guide Sheath include its use in facilitating the introduction of interventional devices during vascular procedures. It is intended for patients undergoing catheter-based interventions where vascular access is required.
Practical Considerations
The Prelude Guide Sheath comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and devices, and clinicians should select the appropriate size based on the specific procedure and patient anatomy.
Frequently Asked Questions
What is the Prelude Guide Sheath used for?
The Prelude Guide Sheath is used to facilitate the introduction of catheters and other interventional devices during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use the Prelude Guide Sheath in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the introduction of interventional devices during vascular procedures.
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.