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 ?
510(k)
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.
FDA-Cleared Indications
- Used to facilitate the introduction and placement of electrophysiology catheters during cardiac electrophysiology procedures.
- Used to provide vascular access and support catheter navigation within the heart and associated blood vessels.
- Intended for use by trained clinicians in hospital or specialized cardiac-care settings.
Clinical Applications
- Providing a steerable conduit for electrophysiology catheters during cardiac mapping procedures.
- Supporting catheter positioning during catheter-based treatment of cardiac arrhythmias when consistent access and control are needed.
- Facilitating navigation through the vascular system to reach cardiac chambers during electrophysiology procedures.
Practical Considerations
- The available sheath and dilator sizes should be matched to the selected catheter, vascular access site and patient anatomy.
- The device is intended for use with compatible electrophysiology catheters and must be handled according to the manufacturer's instructions to preserve steerability and device integrity.
- The access route, anticoagulation strategy, anesthesia or sedation plan and imaging guidance are determined by the treating electrophysiology team.
- MRI safety depends on the specific device model, whether it remains in the patient and the manufacturer's current labeling; the applicable instructions for use should be checked before MRI.
- Contraindications, warnings and complications include those specified in the current labeling and may include vascular injury, bleeding, infection, thrombosis, air embolism, arrhythmia or cardiac perforation.
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.