FDA.report

V-Trak

Primary DI
00816777023933
Brand
V-Trak
Company
MICROVENTION INC.
Model
7118-0723-A2
Catalog number
7118-0723
Device description
HydroFrame 18 Advanced
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816777023933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816777023933008167770239338167770239330816777023933

GMDN Terms

TermDefinition
Neurovascular embolization coilA 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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00842429108543Balloon Guide CatheterBOB-895-USBOB-8952025-09-09
00842429118771V-Grip Detachment ControllerVG900-ALVG5012025-09-01
00842429118795AZUR Detachment Controller45-4001-AL45-40012025-09-01
00816777020116V-Grip Detachment ControllerVG900VG5012025-08-28
00840273201991AZUR Detachment Controller45-4001-0245-40012025-08-28
00840273202028V-Grip Detachment ControllerVG900-MDRVG5012025-08-28
00842429106464V-Grip Detachment ControllerVG900-ISVG5012025-08-28
00811425020852Roadsaver Carotid Atery StentRDS-0520-143RX-MVIRDS-0520-143RX2025-08-01
00811425020869Roadsaver Carotid Atery StentRDS-0530-143RX-MVIRDS-0530-143RX2025-08-01
00811425020876Roadsaver Carotid Atery StentRDS-0540-143RX-MVIRDS-0540-143RX2025-08-01
00811425020883Roadsaver Carotid Atery StentRDS-0625-143RX-MVIRDS-0625-143RX2025-08-01
00811425020890Roadsaver Carotid Atery StentRDS-0630-143RX-MVIRDS-0630-143RX2025-08-01
00811425020906Roadsaver Carotid Atery StentRDS-0725-143RX-MVIRDS-0725-143RX2025-08-01
00811425020913Roadsaver Carotid Atery StentRDS-0730-143RX-MVIRDS-0730-143RX2025-08-01
00811425020920Roadsaver Carotid Atery StentRDS-0825-143RX-MVIRDS-0825-143RX2025-08-01
00811425020937Roadsaver Carotid Atery StentRDS-0830-143RX-MVIRDS-0830-143RX2025-08-01
00811425020944Roadsaver Carotid Atery StentRDS-0840-143RX-MVIRDS-0840-143RX2025-08-01
00811425024652Roadsaver Carotid Atery StentRDS-0616-143RX-MVIRDS-0616-143RX2025-08-01
00811425024669Roadsaver Carotid Atery StentRDS-0718-143RX-MVIRDS-0718-143RX2025-08-01
00811425024676Roadsaver Carotid Atery StentRDS-0820-143RX-MVIRDS-0820-143RX2025-08-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840303714262Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714279Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714286Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714293Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714309Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714316Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714323Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714330Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714347Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714354Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714361Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714378Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714385Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714392Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714408Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714415Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714422Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714439Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714446Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714453Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714460Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714477Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714484Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00810169722039swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722046swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722053swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722060swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722077swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722084swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722091swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26