FDA.reportPublic FDA data

Azur Detachment Controller

Primary DI
10810170012126
Brand
Azur Detachment Controller
Company
MICROVENTION INC.
Model
45-4001
Catalog number
45-4001
Device description
Azur
Published
2016-09-24
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093002000AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610MicroVention, Inc.2009-10-28KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810170012126PackageGS15In Commercial Distribution
00810170012129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017001212610810170012126
00810170012129008101700121298101700121290810170012129

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.

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.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
10842429103125WEB Detachment ControllerWDC-2-MVIWDC-22020-08-31
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

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Primary DI, Brand, Company table
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06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
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06958698053485Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
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06958698053508Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
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00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
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