Flow Re-Direction Endoluminal Device (FRED) System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Flow Re-Direction Endoluminal Device (FRED®) System FDA PMA
- Generic Name
- Intracranial aneurysm flow diverter FDA PMA
Identifiers
- PMA Number
- P180027 FDA PMA
- FDA Product Code
- OUT FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Flow Re-Direction Endoluminal Device (FRED) System is an Intracranial Aneurysm Flow Diverter, classified as a Class III medical device. It is designed to redirect blood flow within the internal carotid artery—from the petrous segment to the terminus—to promote aneurysm occlusion in adult patients aged 22 or older. The device targets wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from parent vessels with diameters between 2.0 mm and 5.0 mm.
The FRED System is supplied as a sterile, single-use endovascular device and is intended for use under fluoroscopic guidance. It requires FDA_PMA authorization (PMA P180027) and is regulated under the Neurology advisory committee classification. Device sizes and configurations are referenced by specific FEI numbers (e.g., 3010079067, 2011171) and must be stored per manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
What types of intracranial aneurysms is the FRED System designed to treat, and what are the key anatomical requirements for use?
The FRED System is specifically designed for wide-necked saccular or fusiform intracranial aneurysms arising from the internal carotid artery. It targets aneurysms with a neck width of 4 mm or greater, or a dome-to-neck ratio of less than 2. Additionally, the parent vessel must have a diameter between 2.0 mm and 5.0 mm, and the procedure is intended for adult patients aged 22 or older.
How is the FRED System supplied, and what precautions should be taken during storage to ensure its integrity?
The FRED System is supplied as a sterile, single-use endovascular device. To maintain sterility and functionality, it must be stored strictly according to the manufacturer’s instructions, which likely include protection from contamination, extreme temperatures, and physical damage.
What regulatory pathway does the FRED System follow, and how is it classified?
The FRED System is classified as a Class III medical device and requires FDA Pre-Market Approval (PMA) under PMA number P180027. It is regulated under the Neurology advisory committee classification and is intended for use in the internal carotid artery from the petrous segment to the terminus.
Are there multiple sizes or configurations available for the FRED System, and how are they identified?
Yes, the FRED System comes in multiple sizes and configurations, each referenced by specific FEI numbers such as 3010079067, 2011171, and others. These FEI numbers correspond to distinct device dimensions or designs, allowing for tailored selection based on anatomical requirements.
Is the FRED System intended for use with fluoroscopic guidance, and why is this important?
Yes, the FRED System is intended for use under fluoroscopic guidance, which provides real-time X-ray imaging to ensure precise placement within the internal carotid artery. This guidance is critical for safely redirecting blood flow and promoting aneurysm occlusion, particularly in complex anatomical locations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180027 | Class III | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA PMA P180027 24 fields · synced Sep 18, 2026