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oval pull-apart sheath dilator
Quinton
Summary: The oval pull-apart sheath dilator is a medical device used primarily in vascular procedures to facilitate the insertion of embolization coils. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K873394 ↗
Decision Date
September 30, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The oval pull-apart sheath dilator by Quinton was cleared through the FDA 510k pathway on September 30, 1987. It is classified as a Class 2 medical device under product code DYB.
What It Is
The oval pull-apart sheath dilator is a specialized tool designed to aid in the insertion of devices like embolization coils into blood vessels. It consists of a sheath and a dilator that can be separated, allowing for precise placement and removal. This device is particularly useful in procedures requiring vascular access and manipulation.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for procedures involving embolization. It is essential for creating a stable access point in blood vessels, facilitating the delivery of therapeutic agents or devices. Patients undergoing treatment for vascular abnormalities, such as aneurysms or arteriovenous malformations, may benefit from its use.
Indications for Use
The oval pull-apart sheath dilator is indicated for use in procedures requiring vascular access, particularly for the delivery of embolization coils. It is suitable for patients with conditions that necessitate precise vascular intervention.
Practical Considerations
Clinicians should consider the compatibility of the sheath dilator with other devices used in the procedure. It is available in various sizes to accommodate different vessel diameters. Proper technique in sheath insertion and removal is crucial to minimize vascular trauma.
Frequently Asked Questions
What is the oval pull-apart sheath dilator used for?
It is used to facilitate the insertion of embolization coils and other devices into blood vessels during vascular procedures.
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 for the delivery 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.