FDA.reportPublic FDA data

Avenir

Primary DI
06970908211331
Brand
Avenir
Company
Shanghai Wallaby Medical Technologies Co., Inc.
Model
10CFR13030
Device description
Embolic Coil
Published
2021-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDevice, Neurovascular Embolization
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173711000Wallaby Avenir Coil SystemWallaby Medical, Inc.2018-05-04HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970908211331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970908211331069709082113316970908211331

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544535295
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970908212079Paragon 8F Balloon Guide CatheteBG8F0852026-04-15
06970908212086Paragon 8F Balloon Guide CatheteBG8F0952026-04-15
06970908212093Paragon 8F Balloon Guide CatheteBG8F0852024-10-11
06970908212109Paragon 8F Balloon Guide CatheteBG8F0952024-10-11
06970908212734Avenir10HSW010082025-01-15
06970908212741Avenir10HSW010102025-01-15
06970908212758Avenir10HSW015102025-01-15
06970908212765Avenir10HSW015152025-01-15
06970908212772Avenir10HSW020122025-01-15
06970908212789Avenir10HSW020202025-01-15
06970908212796Avenir10CSW010082025-01-15
06970908212802Avenir10CSW010102025-01-15
06970908212819Avenir10CSW015102025-01-15
06970908212826Avenir10CSW015152025-01-15
06970908212833Avenir10CSW020122025-01-15
06970908212840Avenir10CSW020202025-01-15
06970908212857Avenir10CSW030202025-01-15
06970908212864Avenir10CSW030302025-01-15
06970908212871Avenir10CSW040302025-01-15
06970908212888Avenir10CSW040402025-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303712053Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712077Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712091Prestige Coil SystemBALT USA LLCKRD2026-07-14
00840303712107Prestige Coil SystemBALT USA LLCKRD2026-07-14
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053362Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053362Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053386Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053386Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053393Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053393Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053409Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053409Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053416Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053416Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053423Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053423Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053430Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053430Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053447Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053447Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053454Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053454Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.KRD2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13