ArtVentive Endoluminal Occlusion System (EOS)

Primary DI
B617PG151
Brand
ArtVentive Endoluminal Occlusion System (EOS)
Company
Artventive Medical Group, Inc.
Model
5mm Implant
Catalog number
EOS PG1-5
Device description
ArtVentive Endoluminal Occlusion System (EOS), 5mm Implant
Published
2024-02-05
Public version status
New
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
K150402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150402000Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.2015-09-25KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B617PG151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, metallicA non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Keep Away From Sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (650) 465-5259customerservice@artventivemedical.com

Regulatory Flags#

DUNS number
044373435
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B617PG1111ArtVentive Endoluminal Occlusion System (EOS) 11mm ImplantEOS PG1-112024-02-05
B617PG181ArtVentive Endoluminal Occlusion System (EOS) 8mm ImplantEOS PG1-82024-02-05
B617PSG161ArtVentive Endoluminal Occlusion System (EOS) 6Fr Guide CatheterEOS PSG1-62024-02-05
B617PSG1751ArtVentive Endoluminal Occlusion System (EOS) 7.5Fr Guide CatheterEOS PSG1-7.52024-02-05

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Primary DI, Brand, Company table
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10857798005130Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005147Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
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