FDA.reportPublic FDA data

Stent

Primary DI
00842429106648
Brand
Stent
Company
Microvention, Inc.
Model
FRED3027-PMA
Catalog number
FRED3027
Device description
FRED 21
Published
2025-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUTIntracranial aneurysm flow diverter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUTIntracranial Aneurysm Flow DiverterUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429106648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429106648008424291066488424291066480842429106648

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal intracranial vascular stentA non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714) 247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842429118689MV Flow Aspiration PumpMVFLOWPMP01-USMVFLOWPMP012026-07-15
00842429118795AZUR Detachment Controller45-4001-AL45-40012025-09-01
00816777020116V-Grip Detachment ControllerVG900VG5012025-08-28
00840273201991AZUR Detachment Controller45-4001-0245-40012025-08-28
00840273202028V-Grip Detachment ControllerVG900-MDRVG5012025-08-28
00842429106464V-Grip Detachment ControllerVG900-ISVG5012025-08-28
00810170018831ERIC Retrieval DeviceER173020-USERIC1730202022-10-12
00810170018848ERIC Retrieval DeviceER174030-USERIC1740302022-10-12
00810170018862ERIC Retrieval DeviceER176044-USERIC1760442022-10-12
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
00812636020471Azur Detachable Helical HydroCoil45-48050545-4805052015-12-29
00812636020488Azur Detachable Helical HydroCoil45-48051045-4805102015-12-29
00812636020495Azur Detachable Helical HydroCoil45-48051545-4805152015-12-29
00812636020501Azur Detachable Helical HydroCoil45-48052045-4805202015-12-29
00810170017841Azur Detachable Helical HydroCoil45-48020245-4802022015-12-29
00810170017858Azur Detachable Helical HydroCoil45-48020445-4802042015-12-29
00810170017865Azur Detachable Helical HydroCoil45-48030245-4803022015-12-29
00810170017902Azur Detachable Helical HydroCoil45-48041045-4804102015-12-29
00810170017933Azur Detachable Helical HydroCoil45-48061045-4806102015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429106570StentMicrovention, Inc.OUT2025-04-22
00842429106587StentMicrovention, Inc.OUT2025-04-22
00842429106594StentMicrovention, Inc.OUT2025-04-22
00842429106600StentMicrovention, Inc.OUT2025-04-22
00842429106617StentMicrovention, Inc.OUT2025-04-22
00842429106624StentMicrovention, Inc.OUT2025-04-22
00842429106631StentMicrovention, Inc.OUT2025-04-22
00842429106655StentMicrovention, Inc.OUT2025-04-22
00842429106662StentMicrovention, Inc.OUT2025-04-22
00842429106679StentMicrovention, Inc.OUT2025-04-22
00842429106686StentMicrovention, Inc.OUT2025-04-22
00842429106693StentMicrovention, Inc.OUT2025-04-22
00842429106709StentMicrovention, Inc.OUT2025-04-22
00842429106723StentMicrovention, Inc.OUT2025-04-22
00842429106730StentMicrovention, Inc.OUT2025-04-22
00842429106747StentMicrovention, Inc.OUT2025-04-22
00842429106754StentMicrovention, Inc.OUT2025-04-22
00842429106761StentMicrovention, Inc.OUT2025-04-22
00842429106778StentMicrovention, Inc.OUT2025-04-22
00842429106785StentMicrovention, Inc.OUT2025-04-22
00842429106792StentMicrovention, Inc.OUT2025-04-22
00842429106808StentMicrovention, Inc.OUT2025-04-22
00842429106815StentMicrovention, Inc.OUT2025-04-22
00842429106822StentMicrovention, Inc.OUT2025-04-22
00842429106839StentMicrovention, Inc.OUT2025-04-22
00842429106846StentMicrovention, Inc.OUT2025-04-22
00842429106853StentMicrovention, Inc.OUT2025-04-22
00842429106860StentMicrovention, Inc.OUT2025-04-22
00763000448929Pipeline TM Flex Embolization Device with Shield Technology TMMicro Therapeutics, Inc.OUT2025-03-11
00763000448936Pipeline TM Flex Embolization Device with Shield Technology TMMicro Therapeutics, Inc.OUT2025-03-11