FDA.reportPublic FDA data

WEB Detachment Controller

Primary DI
00842429103128
Brand
WEB Detachment Controller
Company
Microvention, Inc.
Model
WDC-2-MVI
Catalog number
WDC-2
Device description
WEB Detachment Controller
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P170032003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170032003Woven EndoBridge (WEB) Aneurysm Embolization SystemMicroVention, Inc.2018-12-31OPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842429103125PackageGS15In Commercial Distribution
00842429103128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084242910312510842429103125
00842429103128008424291031288424291031280842429103128

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.

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
00810170012112V-Grip Detachment ControllerVG501VG5012016-09-24
00810170012129Azur Detachment Controller45-400145-40012016-09-24
00810170012136Azur Pushable Helical45-28020245-2802022015-12-29
00810170012143Azur Pushable Helical45-28030245-2803022015-12-29
00810170012150Azur Pushable Helical45-28030445-2803042015-12-29
00810170012167Azur Pushable Helical45-28040245-2804022015-12-29
00810170012174Azur Pushable Helical45-28040445-2804042015-12-29
00810170012181Azur Pushable Helical45-28040645-2804062015-12-29
00810170012198Azur Pushable Helical45-28050445-2805042015-12-29
00810170012204Azur Pushable Helical45-28050645-2805062015-12-29
00810170012211Azur Pushable Helical45-28051045-2805102015-12-29
00810170012228Azur Pushable Helical45-28060645-2806062015-12-29
00810170012235Azur Pushable Helical45-28061045-2806102015-12-29
00810170012242Azur Pushable Helical45-28061445-2806142015-12-29
00810170012259Azur Pushable Helical45-28081045-2808102015-12-29
00810170012266Azur Pushable Helical45-28081445-2808142015-12-29
00810170012273Azur Pushable Helical45-28101445-2810142015-12-29
00810170012440Azur Pushable Helical45-25040445-2504042015-12-29
00810170012457Azur Pushable Helical45-25040645-2504062015-12-29
00810170012464Azur Pushable Helical45-25050445-2505042015-12-29

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
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
00842429107041WEB Aneurysm Embolization SystemMicrovention, Inc.OPR2020-08-30