đź“‹ FDA Reference
flexcath select steerable shealth and dilator
Medtronic Cryocath, Lp
Summary: The FlexCath Select Steerable Sheath is a medical device used in electrophysiology procedures to facilitate catheter navigation. It is primarily used by cardiologists in settings such as hospitals and specialized cardiac centers.
FDA Clearance Information
Pathway
510K
Number
K163268 ↗
Decision Date
February 2, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The FlexCath Select Steerable Sheath and Dilator, manufactured by Medtronic Cryocath, received FDA clearance via the 510(k) pathway on February 2, 2017. It is classified as a Class 2 medical device under product code DYB.
What It Is
The FlexCath Select Steerable Sheath is a specialized tool designed to aid in the navigation and placement of catheters during electrophysiological procedures. Its steerable design allows for precise control and positioning within the vascular system, which is crucial during complex cardiac interventions. The sheath is used to provide a stable conduit for other devices, enhancing procedural efficiency and safety.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as catheter ablation for atrial fibrillation or other arrhythmias. Cardiologists and electrophysiologists utilize it to improve access to the heart's chambers, especially when navigating challenging anatomical pathways. It is typically employed in adult patients undergoing minimally invasive cardiac interventions.
Indications for Use
The FDA-cleared indications for the FlexCath Select Steerable Sheath involve its use in facilitating catheter-based procedures aimed at treating cardiac arrhythmias. It is particularly useful for patients requiring precise catheter placement in the heart.
Practical Considerations
The FlexCath Select is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of electrophysiology catheters and requires careful handling to maintain its steerability and integrity during use. Clinicians should be familiar with its operation to maximize its benefits in complex procedures.
Frequently Asked Questions
What is the FlexCath Select Steerable Sheath used for?
It is used to facilitate the navigation and placement of catheters during electrophysiology procedures, such as catheter ablation for arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in hospital and specialized cardiac center settings.
What are the FDA-cleared indications?
The device is indicated for use in catheter-based procedures to treat cardiac arrhythmias, aiding in precise catheter placement within the heart.
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.