📋 FDA Reference
Ultimum Hemostasis Introducer Model 4076xx
Summary: The Ultimum Hemostasis Introducer is a medical device used to facilitate vascular access and hemostasis during interventional procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K001346 ↗
Decision Date ?
May 24, 2000
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Ultimum Hemostasis Introducer, manufactured by St. Jude Medical, was cleared through the FDA 510(k) pathway on May 24, 2000. It is classified as a Class 2 device under product code DYB.
What It Is
The Ultimum Hemostasis Introducer is a specialized catheter introducer designed to provide vascular access while minimizing bleeding during interventional procedures. It typically consists of a sheath and a dilator, allowing for the introduction of various catheters or devices into the vasculature. Its hemostatic properties help maintain vessel integrity and reduce the risk of bleeding complications.
FDA-Cleared Indications
- Provides vascular access during interventional procedures.
- Facilitates the introduction of catheters, guidewires, and other compatible devices into the vasculature.
- Supports hemostasis during procedures requiring percutaneous vascular access.
Clinical Applications
- Vascular access for angiography and other catheter-based diagnostic procedures.
- Access for embolization procedures, including procedures involving embolization coils.
- Access for interventional radiology and cardiology procedures requiring catheter or device introduction.
- Procedures in which control of bleeding at the percutaneous access site is clinically important.
Practical Considerations
- The introducer is available in different sizes; the selected sheath should match the target vessel, catheter or device, and procedural requirements.
- Use only with compatible guidewires, catheters, and interventional devices according to the device labeling and institutional protocols.
- Insertion and removal require appropriate sterile technique, imaging guidance when indicated, and monitoring for bleeding, vessel injury, thrombosis, infection, or hematoma.
- The FDA record supplied does not establish MRI safety or conditional-use status. MRI compatibility should be confirmed from the current manufacturer labeling before scanning.
- Potential contraindications and precautions include unsuitable access anatomy, local infection, uncontrolled bleeding risk, severe coagulopathy, or inability to maintain safe vascular access.
Procedures that use this device
Frequently Asked Questions
What is the Ultimum Hemostasis Introducer used for?
It is used for vascular access and hemostasis during interventional procedures, such as angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for procedures requiring vascular access and hemostasis, such as the placement of embolization coils.
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.