FDA.reportPublic FDA data

WEB Aneurysm Embolization System

Primary DI
00854111006020
Brand
WEB Aneurysm Embolization System
Company
SEQUENT MEDICAL, INC.
Model
W4-6-S
Catalog number
FGA25060-001
Device description
WEB 21 SLS 6
Published
2019-04-01
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
00854111006020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854111006020008541110060208541110060200854111006020

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at a controlled room temperature in a dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949.830.9600customerserviceus@sequentmedical.com

Regulatory Flags#

DUNS number
796807340
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856956005282WEB Detachment ControllerWDC-1FGA001752019-04-01
00851566003420VIA MicrocatheterVIA-27-154-01FG27154-012016-07-12
00851566003703VIA MicrocatheterVIA-33-133-01FG33133-012016-07-12
00851566003918VIA MicrocatheterVIA-21-154-01FGA21154-012016-07-12
00851566003925VIA MicrocatheterVIA-17-154-01FGA17154-012017-03-31
00854111006006WEB Aneurysm Embolization SystemW4-4-SFGA25040-0012019-04-01
00854111006013WEB Aneurysm Embolization SystemW4-5-SFGA25050-0012019-04-01
00854111006037WEB Aneurysm Embolization SystemW4-7-SFGA25070-0012019-04-01
00854111006044WEB Aneurysm Embolization SystemW4-4-3FGA25040-0302019-04-01
00854111006051WEB Aneurysm Embolization SystemW4-4-4FGA25040-0402019-04-01
00854111006068WEB Aneurysm Embolization SystemW4-5-3FGA25050-0302019-04-01
00854111006075WEB Aneurysm Embolization SystemW4-5-4FGA25050-0402019-04-01
00854111006082WEB Aneurysm Embolization SystemW4-5-5FGA25050-0502019-04-01
00854111006099WEB Aneurysm Embolization SystemW4-6-3FGA25060-0302019-04-01
00854111006105WEB Aneurysm Embolization SystemW4-6-4FGA25060-0402019-04-01
00854111006112WEB Aneurysm Embolization SystemW4-6-5FGA25060-0502019-04-01
00854111006129WEB Aneurysm Embolization SystemW4-6-6FGA25060-0602019-04-01
00854111006136WEB Aneurysm Embolization SystemW4-7-3FGA25070-0302019-04-01
00854111006143WEB Aneurysm Embolization SystemW4-7-4FGA25070-0402019-04-01
00854111006150WEB Aneurysm Embolization SystemW4-7-5FGA25070-0502019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842429106969WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30
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