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pull-apart introducer sheath
Quinton
Summary: The pull-apart introducer sheath by Quinton is a medical device used primarily in interventional radiology and cardiology for the insertion of embolization coils. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K873727 ↗
Decision Date
October 7, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on October 7, 1987. Manufactured by Quinton, it is classified as a Class 2 device under product code DYB.
What It Is
The pull-apart introducer sheath is a medical device designed to facilitate the insertion of other devices, such as embolization coils, into the vascular system. It consists of a sheath that can be split apart to allow for the removal of the sheath without disturbing the position of the inserted device. This is particularly useful in procedures requiring precise placement and minimal disruption.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is employed in procedures involving vascular access and intervention, such as the placement of embolization coils to treat aneurysms or control bleeding. It is used in hospital settings, often in catheterization labs or interventional suites, and is suitable for adult and pediatric populations requiring vascular interventions.
Indications for Use
The pull-apart introducer sheath is indicated for use in procedures requiring the insertion of devices into the vascular system, such as embolization coils. It is suitable for patients needing vascular interventions to address conditions like aneurysms or vascular malformations.
Practical Considerations
The device is available in various sizes to accommodate different vascular anatomies and is compatible with a range of interventional devices. Clinicians should be familiar with the technique of splitting the sheath to ensure the safe removal without displacing the inserted device.
Frequently Asked Questions
What is the pull-apart introducer sheath used for?
It is used to facilitate the insertion of devices like embolization coils into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in vascular interventions requiring the insertion of devices such as 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.