📋 FDA Reference
Ultimum Ev Hemostasis Introducer
Summary: The Ultimum EV Hemostasis Introducer is a medical device used to facilitate vascular access during endovascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140327 ↗
Decision Date ?
March 11, 2014
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Ultimum EV Hemostasis Introducer was cleared through the FDA 510(k) pathway on March 11, 2014. 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 is a specialized catheter introducer designed to provide hemostasis during vascular access procedures. It is used to introduce guidewires and catheters into the vascular system, minimizing blood loss and facilitating smoother procedures. The device is particularly useful in complex endovascular interventions where maintaining hemostasis is critical.
FDA-Cleared Indications
- Facilitation of vascular access during endovascular procedures.
- Introduction of guidewires and catheters into the vascular system.
- Maintenance of hemostasis at the vascular access site during catheter-based procedures.
Clinical Applications
- Providing vascular access for angiography and other diagnostic endovascular procedures.
- Supporting catheter and guidewire access during embolization procedures.
- Supporting access during endovascular stent placement and related catheter-based interventions.
- Maintaining hemostasis during procedures requiring repeated guidewire or catheter exchanges.
Practical Considerations
- The appropriate sheath size should match the planned catheter or device, the target vessel, and the patient's anatomy.
- The introducer is intended for use with compatible guidewires and catheters; clinicians should review the device labeling before use.
- Vascular access should be performed using standard sterile technique and appropriate imaging guidance, such as ultrasound and fluoroscopy when indicated.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and damage to the access vessel.
- MRI compatibility and conditions should be confirmed in the current manufacturer labeling; do not assume the device is MR safe or MR conditional.
Related Literature
The linked study investigated the use of the superficial femoral artery (SFA) for vascular access in patients with hostile groin anatomy. It compared ultrasound-guided SFA puncture to traditional SFA cutdown, finding that ultrasound guidance was a feasible and safe alternative. However, the study was limited by its focus on a specific patient population and procedural context.
Procedures that use this device
Frequently Asked Questions
What is the Ultimum EV Hemostasis Introducer used for?
It is used to facilitate vascular access and maintain hemostasis during endovascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in endovascular procedures requiring vascular access and hemostasis.
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.