FDA.reportPublic FDA data

Azur Detachable Framing Coil

Primary DI
00810170016127
Brand
Azur Detachable Framing Coil
Company
Microvention, Inc.
Model
45-651434
Catalog number
45-651434
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111307000AZUR DETACHABLE 35 PLATINUM COIL SYSTEMMicroVention, Inc.2011-06-15KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810170016127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810170016127008101700161278101700161270810170016127

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA sterile, 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

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
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
00842429118788WEB Detachment ControllerWDC-2-MVI-ALWDC-22026-07-30
00842429118689MV Flow Aspiration PumpMVFLOWPMP01-USMVFLOWPMP012026-07-15
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
00810170018831ERIC Retrieval DeviceER173020-USERIC1730202022-10-12
00810170018848ERIC Retrieval DeviceER174030-USERIC1740302022-10-12
00810170018862ERIC Retrieval DeviceER176044-USERIC1760442022-10-12
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
00812636020471Azur Detachable Helical HydroCoil45-48050545-4805052015-12-29
00812636020488Azur Detachable Helical HydroCoil45-48051045-4805102015-12-29
00812636020495Azur Detachable Helical HydroCoil45-48051545-4805152015-12-29
00812636020501Azur Detachable Helical HydroCoil45-48052045-4805202015-12-29
00810170017841Azur Detachable Helical HydroCoil45-48020245-4802022015-12-29
00810170017858Azur Detachable Helical HydroCoil45-48020445-4802042015-12-29
00810170017865Azur Detachable Helical HydroCoil45-48030245-4803022015-12-29
00810170017902Azur Detachable Helical HydroCoil45-48041045-4804102015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886704080121GALAXY G3Cerenovus, Inc.KRD2017-11-03
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10886704080152GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080206GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704080213GALAXY G3Cerenovus, Inc.KRD2017-11-03
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
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10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
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10886704077121DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077138DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077145DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077152DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077169DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077190DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077213MICRUSFRAMECerenovus, Inc.KRD2016-11-16
10886704077220DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077237DELTAFILLCerenovus, Inc.KRD2016-11-16