FDA.reportPublic FDA data

Penumbra Coil 400

Primary DI
00815948024977
Brand
Penumbra Coil 400
Company
PENUMBRA, INC.
Model
4006C0506-A
Catalog number
4006C0506
Device description
Coil 400 Extra Soft, 5mm x 6cm
Published
2023-03-07
Public version status
New
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
K173614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173614000Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.2018-04-17HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948024977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948024977008159480249778159480249770815948024977

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
191077671
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814548014258Smart Coil400SMTSTD13452016-07-30
00814548014265Smart Coil400SMTSTD13602016-07-30
00814548014272Smart Coil400SMTSTD14452016-07-30
00814548014289Smart Coil400SMTSTD14602016-07-30
00814548014296Smart Coil400SMTSTD15452016-07-30
00814548014302Smart Coil400SMTSTD15602016-07-30
00814548014319Smart Coil400SMTSTD16452016-07-30
00814548014326Smart Coil400SMTSTD16602016-07-30
00814548014333Smart Coil400SMTSTD18452016-07-30
00814548014340Smart Coil400SMTSTD18602016-07-30
00814548014357Smart Coil400SMTSTD09202016-07-30
00814548014364Smart Coil400SMTSTD09302016-07-30
00814548014395Smart Coil400SMTSTD10302016-07-30
00814548014401Smart Coil400SMTSTD10452016-07-30
00814548014418Smart Coil400SMTSTD11452016-07-30
00814548014425Smart Coil400SMTSTD11602016-07-30
00814548014432Smart Coil400SMTSTD12452016-07-30
00814548014449Smart Coil400SMTSTD12602016-07-30
00814548014463Smart Coil400SMTSTD11352016-07-30
00814548014470Smart Coil400SMTSTD12352016-07-30

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