FDA.reportPublic FDA data

Numen Helia

Primary DI
06958698053409
Brand
Numen Helia
Company
MicroPort NeuroTech (Shanghai) Co., Ltd.
Model
3D0110SS
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
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
K260351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260351000Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2026-05-20HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958698053409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958698053409069586980534096958698053409

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.

Regulatory Flags#

DUNS number
551973856
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06958698053355Numen Helia3D0102SS2026-07-13
06958698053362Numen Helia3D0103SS2026-07-13
06958698053379Numen Helia3D0104SS2026-07-13
06958698053386Numen Helia3D0106SS2026-07-13
06958698053393Numen Helia3D0108SS2026-07-13
06958698053416Numen Helia3D1H02SS2026-07-13
06958698053423Numen Helia3D1H03SS2026-07-13
06958698053430Numen Helia3D1H04SS2026-07-13
06958698053447Numen Helia3D1H06SS2026-07-13
06958698053454Numen Helia3D1H08SS2026-07-13
06958698053461Numen Helia3D1H10SS2026-07-13
06958698053478Numen Helia3D1H15SS2026-07-13
06958698053485Numen Helia3D0202SS2026-07-13
06958698053492Numen Helia3D0203SS2026-07-13
06958698053508Numen Helia3D0204SS2026-07-13
06958698011690NumenFRE1012022-03-15
06958698025260Numen3D0102FNM22024-11-06
06958698025277Numen3D0103FNM22024-11-06
06958698025284Numen3D1H02FNM22024-11-06
06958698025291Numen3D1H03FNM22024-11-06

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