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ultraflex ev hemostasis introducer
St Jude Medical
Summary: The Ultraflex EV Hemostasis Introducer is a medical device used primarily in vascular procedures to facilitate the introduction of embolization coils. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K012922 ↗
Decision Date
September 25, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ultraflex EV Hemostasis Introducer was cleared through the FDA 510(k) pathway on September 25, 2001. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Ultraflex EV Hemostasis Introducer is a specialized catheter system designed to provide vascular access and facilitate the delivery of embolization coils. It features a flexible sheath that allows for smooth insertion and navigation within blood vessels, minimizing trauma to the vessel walls. This device is essential in procedures requiring precise placement of embolic materials to control bleeding or occlude blood flow to specific areas.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures involving embolization, such as treating arteriovenous malformations or controlling gastrointestinal bleeding. It is particularly useful in hospital settings where minimally invasive techniques are preferred. Patients who benefit from this device include those with vascular abnormalities or conditions requiring targeted embolization.
Indications for Use
The FDA-cleared indications for the Ultraflex EV Hemostasis Introducer include its use in delivering embolization coils to manage bleeding or occlude blood vessels. It is intended for patients requiring vascular intervention to address conditions like aneurysms or varices.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and is compatible with standard embolization coils. Clinicians should ensure proper sizing and technique to minimize complications. Familiarity with vascular anatomy and fluoroscopic guidance is essential for effective use.
Frequently Asked Questions
What is the Ultraflex EV Hemostasis Introducer used for?
It is used to facilitate the introduction of embolization coils in vascular procedures to control bleeding or occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access and embolization.
What are the FDA-cleared indications?
The device is indicated for delivering embolization coils to manage bleeding or occlude blood vessels in patients with vascular conditions.
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.