FDA.reportPublic FDA data

AZUR

Primary DI
00816777024381
Brand
AZUR
Company
MICROVENTION INC.
Model
45-780304-L
Catalog number
45-780304
Device description
Azur CX Detachable
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

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
00816777024381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816777024381008167770243818167770243810816777024381

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep away from sunlight.

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
false
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
Primary DIBrandCompanyProduct codePublished
00763000936594Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936600Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936617Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936624Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936631Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936648Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936655Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936662Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936679Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936686Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936693Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936709Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936716Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936723Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936730Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936747Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
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