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deseret introducer set
Parke-Davis
Summary: The Deseret Introducer Set is a medical device used primarily for vascular access during embolization procedures. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K844840 ↗
Decision Date
May 16, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Deseret Introducer Set was cleared through the FDA 510(k) process on May 16, 1985. Manufactured by Parke-Davis, it is classified as a Class 2 device under product code DYB.
What It Is
The Deseret Introducer Set is designed to facilitate the insertion of catheters and other devices into the vascular system. It typically includes a sheath and dilator, allowing for smooth and controlled access to blood vessels. This device is essential for procedures requiring precise vascular entry, minimizing trauma to the vessel wall.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Deseret Introducer Set is employed in procedures such as embolization, where it provides a stable conduit for the delivery of coils or other embolic materials. It is suitable for use in hospital settings, particularly in catheterization labs and operating rooms, and is applicable to a wide range of patient populations requiring vascular interventions.
Indications for Use
The FDA indications for the Deseret Introducer Set include its use in procedures where vascular access is necessary, such as the placement of embolization coils. It is intended for patients requiring controlled and precise entry into the vascular system.
Practical Considerations
The Deseret Introducer Set is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard catheterization equipment, and clinicians should be familiar with the technique of sheath insertion to ensure optimal outcomes.
Frequently Asked Questions
What is the Deseret Introducer Set used for?
The Deseret Introducer Set is used for gaining vascular access during procedures like embolization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access, such as the placement of 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.