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ultra-flex hemostasis introducer model 406xxx
Daig
Summary: The Ultra-Flex Hemostasis Introducer is a medical device used to facilitate the introduction of catheters or other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K994334 ↗
Decision Date
May 15, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ultra-Flex Hemostasis Introducer by Daig was cleared through the FDA 510k pathway on May 15, 2000. It is classified as a Class 2 device under product code DYB.
What It Is
The Ultra-Flex Hemostasis Introducer is a flexible sheath designed to provide vascular access during procedures requiring the insertion of catheters or other devices. It features a hemostasis valve to minimize blood loss during catheter exchanges. This device is essential in maintaining vascular access while reducing the risk of bleeding complications.
Clinical Applications
This device is commonly used in interventional cardiology and radiology during procedures such as angiography, embolization, and catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites, and is used for adult and pediatric patients requiring vascular access.
Indications for Use
The Ultra-Flex Hemostasis Introducer is indicated for use in patients requiring vascular access for the introduction of diagnostic or therapeutic devices. It is particularly useful in procedures involving embolization coils where precise device placement is critical.
Practical Considerations
The introducer is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with a range of catheters and guidewires, and clinicians should ensure proper sizing and technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Ultra-Flex Hemostasis Introducer used for?
It is used to facilitate the introduction of catheters or other devices into the vascular system while minimizing blood loss.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
It is indicated for vascular access in procedures requiring the introduction of diagnostic or therapeutic devices, particularly in embolization.
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.