đź“‹ FDA Reference
sureflex steerable guiding sheath kit
Baylis Medical
Summary: The SureFlex Steerable Guiding Sheath Kit is a medical device used to facilitate catheter navigation in vascular procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K122926 ↗
Decision Date
January 24, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SureFlex Steerable Guiding Sheath Kit was cleared through the FDA 510(k) pathway on January 24, 2013. It is manufactured by Baylis Medical and classified as a Class 2 device under product code DYB.
What It Is
The SureFlex Steerable Guiding Sheath Kit is a device designed to aid in the navigation and placement of catheters within the vascular system. It features a steerable sheath that allows for precise control and positioning, which is crucial during complex vascular procedures. This device enhances the clinician's ability to access difficult-to-reach areas, improving procedural outcomes.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures requiring precise catheter placement, such as embolization or other endovascular interventions. It is particularly useful in settings where vascular access is challenging, such as in patients with tortuous anatomy. The device is typically used in hospitals and specialized clinics by trained healthcare professionals.
Indications for Use
The SureFlex Steerable Guiding Sheath Kit is indicated for use in procedures that require the navigation of catheters through the vascular system. It is suitable for patients undergoing treatments that involve embolization coils or other vascular interventions.
Practical Considerations
The SureFlex Steerable Guiding Sheath Kit comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and embolization devices. Clinicians should be familiar with the device's steering mechanism to maximize its utility during procedures.
Frequently Asked Questions
What is the SureFlex Steerable Guiding Sheath Kit used for?
It is used to facilitate the navigation and placement of catheters in vascular procedures, particularly in challenging anatomical situations.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the navigation of catheters for vascular access, particularly in embolization and other endovascular interventions.
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.