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microslider tearaway introducer set
Galt Medical
Summary: The microslider tearaway introducer set by Galt Medical is a device used primarily in vascular procedures to facilitate the insertion of catheters or other devices. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K123430 ↗
Decision Date
April 12, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The microslider tearaway introducer set was cleared through the FDA 510(k) pathway on April 12, 2013. It is manufactured by Galt Medical and classified as a Class 2 device under product code DYB.
What It Is
The microslider tearaway introducer set is a medical device designed to assist in the insertion of catheters or other interventional devices into the vascular system. It features a tearaway sheath that allows for easy removal after the catheter is in place, minimizing trauma to the vessel. The device is typically used in conjunction with guidewires and is essential in procedures requiring vascular access.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, angiography, and the placement of stents or coils. It is particularly useful in settings where precise vascular access is required, such as in the treatment of aneurysms or vascular malformations. The device is suitable for adult patients and can be used in both inpatient and outpatient settings.
Indications for Use
The FDA-cleared indications for this device include facilitating the introduction of catheters and other devices into the vascular system. It is particularly indicated for use in procedures involving embolization coils, which are used to treat vascular anomalies.
Practical Considerations
The microslider tearaway introducer set is available in various sizes to accommodate different catheter diameters. It is compatible with standard guidewires and catheters, making it versatile for various procedures. Clinicians should be familiar with the tearaway technique to ensure smooth removal of the sheath without dislodging the catheter.
Frequently Asked Questions
What is the microslider tearaway introducer set used for?
It is used to facilitate the insertion of catheters or other devices into the vascular system, particularly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device for vascular access during various procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system, especially in procedures involving embolization coils.
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.