FDA.reportPublic FDA data

Azur Pure Helical

Primary DI
10810170018142
Brand
Azur Pure Helical
Company
MICROVENTION INC.
Model
45-080406
Catalog number
45-080406
Device description
Azur
Published
2015-12-29
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
K122543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122543000AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35MicroVention, Inc.2012-11-28KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810170018142PackageGS13In Commercial Distribution
00810170018145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017001814210810170018142
00810170018145008101700181458101700181450810170018145

GMDN Terms#

Term, Definition table
TermDefinition
Adenovirus immunoglobulin A (IgA) antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to Adenovirus in a clinical specimen.

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
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
10810170018265Azur Pure Helical45-08082045-0808202015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857798005093Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005109Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005123Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005130Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005147Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
00763000495619Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
10841156105655GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105662GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
10841156105679GEL-BLOCKTELEFLEX INCORPORATEDKRD2022-12-29
07613327578577Target TetraStryker CorporationKRD2022-12-19
07613327578591Target TetraStryker CorporationKRD2022-12-19
07613327578607Target TetraStryker CorporationKRD2022-12-19
07613327578638Target TetraStryker CorporationKRD2022-12-19
07613327578676Target TetraStryker CorporationKRD2022-12-19
07613327578683Target TetraStryker CorporationKRD2022-12-19
07613327578690Target TetraStryker CorporationKRD2022-12-19
07613327578706Target TetraStryker CorporationKRD2022-12-19
07613327578737Target TetraStryker CorporationKRD2022-12-19
07613327578744Target TetraStryker CorporationKRD2022-12-19
07613327580099Target TetraStryker CorporationKRD2022-12-19
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
10841156106591GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23
10841156106614GEL-BEADTELEFLEX INCORPORATEDKRD2020-04-23