đź“‹ FDA Reference
spreadable sheath introducer set
Neostar Medical Technologies
Summary: The spreadable sheath introducer set is a medical device used primarily in interventional radiology for procedures involving embolization coils. It is typically used by interventional radiologists to facilitate the introduction of devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K960625 ↗
Decision Date
August 8, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The spreadable sheath introducer set by Neostar Medical Technologies was cleared through the FDA 510(k) pathway on August 8, 1996. It is classified as a Class 2 device under product code DYB.
What It Is
The spreadable sheath introducer set is designed to aid in the insertion of medical devices into the vascular system. It consists of a sheath that can be spread to accommodate the passage of catheters or other instruments. This device is particularly useful in minimizing trauma to the vessel wall during insertion, thereby reducing the risk of complications.
Clinical Applications
This device is commonly used in interventional radiology, particularly during procedures that involve the placement of embolization coils to treat vascular abnormalities such as aneurysms or arteriovenous malformations. It is used in hospital settings, often in catheterization labs or interventional suites, and is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring the introduction of embolization coils into the vascular system. It is intended for patients who need vascular access for the treatment of conditions like aneurysms.
Practical Considerations
The spreadable sheath introducer set is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard interventional radiology equipment and requires careful handling to ensure proper placement and minimize vessel trauma.
Frequently Asked Questions
What is the spreadable sheath introducer set used for?
It is used to facilitate the introduction of medical devices, such as embolization coils, into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists commonly use this device in procedures involving vascular access and embolization.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils into the vascular system, such as treating aneurysms.
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.