FDA.reportPublic FDA data

HydroSoft Helical

Primary DI
00812636026022
Brand
HydroSoft Helical
Company
MICROVENTION INC.
Model
100406H2HS-V[ER]
Catalog number
100406H2HS-V
Device description
V-Trak
Published
2018-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812636026022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812636026022008126360260228126360260220812636026022

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)247-8000customerservice@microvention.c

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
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 DI, Brand, Company table
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00763000936631Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
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00763000936662Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
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00763000936686Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936693Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936709Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
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00763000936723Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
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00763000936754Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936761Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936778Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936785Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936792Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936808Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936815Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936822Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936839Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936846Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936853Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936860Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936877Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936884Concerto Versa™MEDTRONIC, INC.KRD2026-02-27