FDA.reportPublic FDA data

Azur Pushable Helical

Primary DI
00810170014499
Brand
Azur Pushable Helical
Company
Microvention, Inc.
Model
45-280514
Catalog number
45-280514
Device description
Azur
Published
2015-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
10810170014496PackageGS13In Commercial Distribution
00810170014499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017001449610810170014496
00810170014499008101700144998101700144990810170014499

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

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
00842429106563Balloon CatheterBC0210M-USBC0210M2022-06-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714682Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714699Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00763000495626Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28