FDA.reportPublic FDA data

WEB Detachment Controller

Primary DI
00856956005282
Brand
WEB Detachment Controller
Company
SEQUENT MEDICAL, INC.
Model
WDC-1
Catalog number
FGA00175
Device description
WEB Detachment Controller
Published
2019-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10856956005289PackageGS15In Commercial Distribution
00856956005282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085695600528910856956005289
00856956005282008569560052828569560052820856956005282

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, electronic, single-useA noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device.

Storage And Handling#

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

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
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
00854111006020WEB Aneurysm Embolization SystemW4-6-SFGA25060-0012019-04-01
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