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ultimum hemostasis introducer model 4076xx
St. Jude Medical
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
510K
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.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as angiography, embolization, and other interventional radiology or cardiology procedures. It is particularly useful in settings where precise hemostasis is critical, such as in patients with coagulopathies or those on anticoagulation therapy. The device is used in both hospital and outpatient settings.
Indications for Use
The Ultimum Hemostasis Introducer is indicated for use in procedures requiring vascular access and hemostasis, such as the placement of embolization coils. It is suitable for patients undergoing interventional procedures where bleeding control is essential.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and wires, making it versatile for different interventional techniques. Clinicians should be familiar with the device's insertion technique to ensure optimal performance and patient safety.
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.