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lim precision steerable ts steerable sheath dilator
Keystone Heart
Summary: The lim precision steerable ts steerable sheath dilator by Keystone Heart is a medical device used in procedures requiring precise catheter navigation, often employed by interventional cardiologists. It aids in the accurate placement of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K202226 ↗
Decision Date
December 15, 2020
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on December 15, 2020, under the product code DYB. It is manufactured by Keystone Heart and classified as a Class 2 medical device.
What It Is
The lim precision steerable ts steerable sheath dilator is a specialized medical device designed to facilitate the navigation and placement of catheters within the vascular system. It features a steerable sheath that allows for precise control and maneuverability, which is crucial during complex interventional procedures. This device is particularly useful in navigating tortuous vascular anatomy and ensuring accurate delivery of therapeutic devices such as embolization coils.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, where precise catheter placement is essential. It is particularly beneficial in procedures involving embolization, where accurate delivery of coils is necessary to occlude blood vessels. The device is used in hospitals and specialized clinics, primarily by interventional cardiologists and radiologists treating conditions such as aneurysms or arteriovenous malformations.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring the placement of embolization coils. It is intended for patients undergoing treatment for vascular abnormalities where precise catheter navigation is needed.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard catheterization equipment, but clinicians should ensure proper sizing and compatibility with other devices used in the procedure. Mastery of steerable sheath techniques is recommended for optimal use.
Frequently Asked Questions
What is lim precision steerable ts steerable sheath dilator used for?
It is used for precise catheter navigation and placement in procedures requiring embolization, such as treating vascular abnormalities.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device in hospital and specialized clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of embolization coils to treat vascular abnormalities.
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.