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tearaway introducer sheath microslide tearaway introducer
Galt Medical
Summary: The Tearaway Introducer Sheath Microslide by Galt Medical is a device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K153533 ↗
Decision Date
July 5, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Tearaway Introducer Sheath Microslide by Galt Medical was cleared via the FDA 510k pathway on July 5, 2016. It is a Class 2 medical device under product code DYB.
What It Is
The Tearaway Introducer Sheath Microslide is a medical device designed to aid in the insertion of catheters and other interventional devices into the vascular system. It features a tearaway design that allows for easy removal once the catheter is in place, minimizing trauma to the vessel. This device is particularly useful in procedures requiring precise vascular access.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise catheter placement is crucial. It is suitable for use in both hospital and outpatient settings, and is often employed in patients requiring vascular interventions, including those with vascular anomalies or requiring embolization coils.
Indications for Use
The FDA indications for this device include facilitating the insertion of catheters into the vascular system. It is intended for use in patients who require vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The Tearaway Introducer Sheath Microslide is available in various sizes to accommodate different catheter sizes and patient anatomies. It is compatible with standard vascular access techniques and is designed for single-use to maintain sterility and reduce infection risk.
Frequently Asked Questions
What is the Tearaway Introducer Sheath Microslide used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for facilitating the insertion of catheters into the vascular system for diagnostic or therapeutic procedures.
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.