FDA.reportPublic FDA data

WEB Detachment Controller

Primary DI
10842429103125
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
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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, single-use, sterileA sterile, noninvasive, hand-held, battery-powered unit intended to deliver a low-level electric current to break the connection between a vascular (neurovascular or peripheral) implantable device, 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 desired electrically unstable detachment point. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30816777026706Syringe Kit - StrokeMVSK60MVSK602021-11-26
30816777025907Tubing Kit - StrokeMVTK110MVTK1102021-11-26
10810170018098Azur Pure Helical45-08030245-0803022015-12-29
10810170018104Azur Pure Helical45-08030445-0803042015-12-29
10810170018111Azur Pure Helical45-08030645-0803062015-12-29
10810170018128Azur Pure Helical45-08040245-0804022015-12-29
10810170018135Azur Pure Helical45-08040445-0804042015-12-29
10810170018142Azur Pure Helical45-08040645-0804062015-12-29
10810170018159Azur Pure Helical45-08041045-0804102015-12-29
10810170018166Azur Pure Helical45-08050445-0805042015-12-29
10810170018173Azur Pure Helical45-08050645-0805062015-12-29
10810170018180Azur Pure Helical45-08051045-0805102015-12-29
10810170018197Azur Pure Helical45-08051445-0805142015-12-29
10810170018203Azur Pure Helical45-08060645-0806062015-12-29
10810170018210Azur Pure Helical45-08061045-0806102015-12-29
10810170018227Azur Pure Helical45-08061445-0806142015-12-29
10810170018234Azur Pure Helical45-08062045-0806202015-12-29
10810170018241Azur Pure Helical45-08081045-0808102015-12-29
10810170018258Azur Pure Helical45-08081445-0808142015-12-29
10810170018265Azur Pure Helical45-08082045-0808202015-12-29

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
00842429103128WEB 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