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ultimum ev hemostasis introducer 14f ultimum ev hemostasis introducer 16f ultimum ev hemostasis introducer 18f
St Jude Medical
Summary: The Ultimum EV Hemostasis Introducer is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K003729 ↗
Decision Date
January 3, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ultimum EV Hemostasis Introducer, manufactured by St Jude Medical, was cleared through the FDA 510(k) pathway on January 3, 2001. It is classified as a Class 2 medical device under the product code DYB.
What It Is
The Ultimum EV Hemostasis Introducer is a sheath introducer designed to provide vascular access for the introduction of catheters and other interventional devices. It features a hemostasis valve to minimize blood loss during procedures. The device is available in various sizes, including 14F, 16F, and 18F, to accommodate different clinical needs.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures, such as angiography, angioplasty, and embolization. It is suitable for use in hospital settings, particularly in catheterization labs. The introducer is designed for adult patients requiring vascular access for diagnostic or therapeutic interventions.
Indications for Use
The FDA indications suggest that the Ultimum EV Hemostasis Introducer is intended for patients needing vascular access for procedures involving embolization coils or other interventional devices. It is used to facilitate the safe and effective introduction of these devices into the vascular system.
Practical Considerations
Clinicians should select the appropriate introducer size based on the specific procedure and patient anatomy. The device is compatible with a range of catheters and interventional tools. Proper technique is essential to minimize complications such as bleeding or vascular injury.
Frequently Asked Questions
What is the Ultimum EV Hemostasis Introducer used for?
It is used to provide vascular access for the introduction of catheters and interventional devices during procedures like angiography and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access in procedures involving embolization coils and other interventional devices.
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.