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large bore splittable introducer kit
Thomas Medical Products
Summary: The large bore splittable introducer kit is a medical device used to facilitate the insertion of catheters or other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K043438 ↗
Decision Date
February 15, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The large bore splittable introducer kit by Thomas Medical Products was cleared through the FDA 510k pathway on February 15, 2005. It is a Class 2 device under product code DYB.
What It Is
The large bore splittable introducer kit is designed to provide a pathway for the insertion of catheters and other medical devices into large vessels. It consists of a sheath that can be split and removed once the device is in place, minimizing trauma to the vessel. This is particularly useful in procedures requiring the introduction of large devices or multiple catheters.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as the placement of embolization coils, stents, or other vascular devices. It is suitable for use in hospital settings, particularly in catheterization labs or interventional suites, and is used in adult and pediatric patient populations requiring vascular access.
Indications for Use
The FDA-cleared indications for this device include its use in procedures that require the introduction of large or multiple devices into the vascular system. It is indicated for patients undergoing interventions such as embolization or stent placement.
Practical Considerations
The introducer kit typically comes in various sizes to accommodate different vessel diameters and device sizes. It is important to select the appropriate size to ensure compatibility with the intended device and minimize vessel trauma. Proper technique in splitting and removing the sheath is crucial to prevent complications.
Frequently Asked Questions
What is the large bore splittable introducer kit 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 in hospital settings.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring the introduction of large or multiple devices into the vascular system, such as embolization or stent placement.
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.