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sureflex hd steerable sheath versacross hd steerable sheath
Baylis Medical
Summary: The SureFlex HD Steerable Sheath is a medical device used to facilitate catheter navigation in complex cardiac procedures. It is primarily used by cardiologists and electrophysiologists during interventions requiring precise catheter placement.
FDA Clearance Information
Pathway
510K
Number
K231227 ↗
Decision Date
December 20, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SureFlex HD Steerable Sheath by Baylis Medical was cleared via the FDA 510(k) pathway on December 20, 2023. It is classified as a Class 2 device under product code DYB.
What It Is
The SureFlex HD Steerable Sheath is a specialized medical device designed to aid in the navigation and positioning of catheters within the cardiac anatomy. It features a steerable tip that allows for enhanced maneuverability and control during procedures. This device is particularly useful in complex cardiac interventions where precise catheter placement is critical.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as atrial fibrillation ablation, where accurate catheter positioning is essential. It is also utilized in interventional cardiology for procedures requiring access to hard-to-reach areas of the heart. The SureFlex HD is suitable for use in adult patients undergoing these specialized cardiac interventions.
Indications for Use
The FDA has cleared this device for use in procedures requiring catheter navigation within the heart. It is indicated for patients undergoing cardiac interventions that demand precise catheter placement, such as ablations or other electrophysiological studies.
Practical Considerations
The SureFlex HD Steerable Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and is designed for single-use to maintain sterility. Clinicians should be familiar with the device's steering mechanism to optimize its use during procedures.
Frequently Asked Questions
What is the SureFlex HD Steerable Sheath used for?
It is used to facilitate the navigation and positioning of catheters during complex cardiac procedures, such as ablations.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in interventional and electrophysiology labs.
What are the FDA-cleared indications?
It is indicated for use in cardiac procedures requiring precise catheter navigation and placement.
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.