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sapphire elevare sapphire
Omm Imports, Inc. D/B/A Zero Gravity
Summary: The Sapphire Elevare Sapphire is a medical device used in the management of aortic conditions, specifically in procedures involving aortic stent-grafts. It is typically utilized by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K172555 ↗
Decision Date
May 1, 2018
Product Code
OLP
Device Class
Class 2
Evidence
0 studies
The Sapphire Elevare Sapphire was cleared through the FDA's 510(k) pathway on May 1, 2018. It is manufactured by Omm Imports, Inc. and classified as a Class 2 device under product code OLP.
What It Is
The Sapphire Elevare Sapphire is a specialized medical device designed for use in aortic stent-graft procedures. It functions by providing support and structure to the aorta, helping to manage conditions such as aneurysms or dissections. The device is typically used in minimally invasive procedures, offering an alternative to open surgical repair.
Clinical Applications
This device is commonly used in vascular surgery and interventional radiology settings. It is particularly relevant for patients with aortic aneurysms or dissections, where endovascular repair is indicated. The device is suitable for use in hospitals and specialized vascular centers, catering to adult and elderly patient populations who are at risk for aortic complications.
Indications for Use
The FDA-cleared indications for the Sapphire Elevare Sapphire include its use in managing aortic conditions that require stent-graft placement. It is intended for patients with aortic aneurysms or dissections, providing a minimally invasive treatment option.
Practical Considerations
When considering the use of this device, clinicians should be aware of the typical sizing options available to match patient anatomy. Compatibility with existing endovascular systems should be verified, and practitioners should be skilled in endovascular techniques to ensure optimal outcomes.
Frequently Asked Questions
What is Sapphire Elevare Sapphire used for?
It is used for managing aortic conditions, specifically in procedures involving aortic stent-grafts.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in aortic conditions requiring stent-graft placement, such as aneurysms or dissections.
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.