đź“‹ FDA Reference
modification to ultimum ev hemostasis introducer 22f
St Jude Medical
Summary: The Ultimum EV Hemostasis Introducer 22F is a medical device used to facilitate vascular access and hemostasis. It is primarily used by interventional cardiologists and radiologists in procedures requiring large-bore access.
FDA Clearance Information
Pathway
510K
Number
K023447 ↗
Decision Date
October 31, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ultimum EV Hemostasis Introducer 22F was cleared through the FDA 510(k) pathway on October 31, 2002. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Ultimum EV Hemostasis Introducer 22F is a specialized catheter introducer designed to provide vascular access while minimizing bleeding. It features a hemostatic valve that helps maintain hemostasis during the insertion of large-diameter catheters or other devices. This introducer is particularly useful in procedures that require the insertion of embolization coils or other interventional tools.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures such as embolization, where large-bore access is necessary. It is suitable for use in both hospital and outpatient settings, and is often employed in the treatment of patients requiring vascular interventions, such as those with aneurysms or vascular malformations.
Indications for Use
The FDA-cleared indications for this device include facilitating vascular access and maintaining hemostasis during procedures that require the insertion of large-diameter devices. It is intended for patients undergoing interventional procedures that necessitate such access.
Practical Considerations
The Ultimum EV Hemostasis Introducer 22F is typically available in various lengths to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional devices. Clinicians should be familiar with the technique for inserting and securing the introducer to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Ultimum EV Hemostasis Introducer 22F used for?
It is used to facilitate vascular access and maintain hemostasis during interventional procedures requiring large-bore access.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access and maintaining hemostasis during procedures that require the insertion of large-diameter 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.