FDA.reportPublic FDA data

WEB Aneurysm Embolization System

Primary DI
00842429106969
Brand
WEB Aneurysm Embolization System
Company
Microvention, Inc.
Model
W4-4-3-MVI-3
Catalog number
W4-4-3
Device description
WEB 21 SL 4x3
Published
2020-08-30
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
OPRIntrasaccular Flow Disruption Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPRIntrasaccular Flow Disruption DeviceUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170032000Woven EndoBridge (WEB) Aneurysm Embolization SystemMicroVention, Inc.2018-12-31OPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429106969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429106969008424291069698424291069690842429106969

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA sterile, non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) 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
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842429108574BOBBY/SOFIA KitSF6131-B895-USSF6131-B8952025-04-30
00842429113608ISAACINN6150SIM2-3DINN6150SIM2-3D2025-04-30
00842429113615ISAACINN6150SIM3-3DINN6150SIM3-3D2025-04-30
00842429113622ISAACINN6140TIP45INN6140TIP452025-04-30
00842429108444SofiaDA6115ST-GC-ODDA6115ST2024-10-18
00842429108451SofiaDA6125ST-GC-ODDA6125ST2024-10-18
00842429108468SofiaDA6131ST-GC-ODDA6131ST2024-10-18
00842429118092AccessISC5115ST-RAISC5115ST2024-10-18
00842429117705SOFIA 88DA8115ST-DAC-USDA8115ST2023-06-15
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
04987350999795Sofia 5F-125cm STRDA5125STDA5125ST2016-09-24
00816777025913Sofia 5F-125cm STRDA5125ST-EDA5125ST2018-08-07
00816777025920Sofia 5F-115cm STRDA5115ST-EDA5115ST2018-08-07
00812636020082Sofia 5F-115cm STRDA5115STDA5115ST2016-09-24
00812636020419Sofia 6F-115cm STRDA6115STDA6115ST2016-09-24
00812636020426Sofia 6F-125cm STRDA6125STDA6125ST2016-09-24
00812636020433Sofia 6F-135cm STRDA6135STDA6135ST2016-09-24
00812636020440Sofia 6F-115cm STRDA6115STDA6115ST2016-09-24
00812636020457Sofia 6F-125cm STRDA6125STDA6125ST2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429118788WEB Detachment ControllerMicrovention, Inc.OPR2026-07-30
00842429117996WEB 17 SL 6x2Microvention, Inc.OPR2023-04-26
00842429118009WEB 17 SL 7x2Microvention, Inc.OPR2023-04-26
00842429110799WEBMicrovention, Inc.OPR2021-05-31
00842429110805WEBMicrovention, Inc.OPR2021-05-31
00842429110812WEBMicrovention, Inc.OPR2021-05-31
00842429110829WEBMicrovention, Inc.OPR2021-05-31
00842429110836WEBMicrovention, Inc.OPR2021-05-31
00842429110843WEBMicrovention, Inc.OPR2021-05-31
00842429110850WEBMicrovention, Inc.OPR2021-05-31
00842429110867WEBMicrovention, Inc.OPR2021-05-31
00842429110874WEBMicrovention, Inc.OPR2021-05-31
00842429110881WEBMicrovention, Inc.OPR2021-05-31
00842429110898WEBMicrovention, Inc.OPR2021-05-31
00842429110904WEBMicrovention, Inc.OPR2021-05-31
00842429110911WEBMicrovention, Inc.OPR2021-05-31
00842429110928WEBMicrovention, Inc.OPR2021-05-31
00842429110935WEBMicrovention, Inc.OPR2021-05-31
00842429110942WEBMicrovention, Inc.OPR2021-05-31
00842429110959WEBMicrovention, Inc.OPR2021-05-31
00842429110966WEBMicrovention, Inc.OPR2021-05-31
00842429103128WEB Detachment ControllerMicrovention, Inc.OPR2020-08-31
10842429103125WEB Detachment ControllerMICROVENTION INC.OPR2020-08-31
00842429106976WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30
00842429106983WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30
00842429106990WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30
00842429107003WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30
00842429107010WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30
00842429107027WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30
00842429107034WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30