📋 FDA Reference
Prelude Guide Sheath
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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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of the introduction of interventional devices into the vasculature during vascular procedures.
Clinical Applications
- Providing vascular access for angiography and diagnostic catheter procedures.
- Supporting catheter and device introduction during embolization procedures.
- Maintaining a stable access route during catheter-based vascular interventions.
- Allowing exchange of compatible catheters and other interventional devices during a procedure.
Practical Considerations
- The sheath is available in different sizes and configurations; clinicians select the appropriate size based on the access vessel, procedural device, and patient anatomy.
- It must be used with compatible guidewires, catheters, and interventional devices according to the product labeling and instructions for use.
- Access is commonly obtained through a peripheral artery or vein, with placement confirmed and monitored using fluoroscopy or other appropriate imaging.
- MRI safety depends on the specific product configuration and labeling; the exact model should be checked before an MRI examination.
- Potential access-related complications include bleeding, hematoma, vessel injury, infection, thrombosis, and distal ischemia. Patient-specific contraindications and precautions should be reviewed before use.
Procedures that use this device
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.