đź“‹ FDA Reference
Pull-Apart Introducer Sheath
Quinton
Product: Argyle — all models and sizes
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 ?
510(k)
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.
FDA-Cleared Indications
- Introduction of catheters or other interventional devices into the vascular system during procedures requiring vascular access.
- Facilitation of embolization procedures, including delivery of embolization coils or similar devices.
- Removal from around an indwelling device when withdrawing the sheath through the device is not appropriate.
Clinical Applications
- Vascular access for endovascular embolization procedures.
- Delivery of embolization coils during treatment of selected aneurysms, pseudoaneurysms, arteriovenous malformations, or active bleeding.
- Introduction of interventional catheters or other devices during procedures performed in an angiography or catheterization suite.
Practical Considerations
- The appropriate sheath diameter and length depend on the access vessel, target anatomy, catheter or embolization device, and procedural approach.
- The sheath must be compatible with the device being introduced and large enough to permit its passage without excessive resistance.
- Clinicians must use the manufacturer's technique for splitting and removing the sheath to reduce the risk of device displacement or vascular injury.
- This is a temporary, single-procedure access device; it is not intended to remain implanted or provide long-term vascular access.
- MRI safety and conditional-use information should be confirmed in the current product labeling. Do not assume MRI compatibility from the product category alone.
Procedures that use this 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.