ArtVentive Endoluminal Occlusion System (EOS) EOS PG1-11

GUDID B617PG1111

ArtVentive Endoluminal Occlusion System (EOS), 11mm Implant

Artventive Medical Group, Inc.

Non-neurovascular embolization plug, metallic

• Primary Device ID: B617PG1111
• NIH Device Record Key: ab78d146-6b03-49ba-b19e-a541eb4405b2
• Commercial Distribution Discontinuation: 2099-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArtVentive Endoluminal Occlusion System (EOS)
• Version Model Number: 11mm Implant
• Catalog Number: EOS PG1-11
• Company DUNS: 044373435
• Company Name: Artventive Medical Group, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com
• Phone: +1 (650) 465-5259
• Email: customerservice@artventivemedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep Away From Sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B617PG1111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150402

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-13
• Device Publish Date: 2024-02-05

On-Brand Devices [ArtVentive Endoluminal Occlusion System (EOS) ]

• B617PSG1751: ArtVentive Endoluminal Occlusion System (EOS), 7.5Fr Guide Catheter
• B617PSG161: ArtVentive Endoluminal Occlusion System (EOS), 6F Guide Catheter
• B617PG181: ArtVentive Endoluminal Occlusion System (EOS), 8mm Implant
• B617PG151: ArtVentive Endoluminal Occlusion System (EOS), 5mm Implant
• B617PG1111: ArtVentive Endoluminal Occlusion System (EOS), 11mm Implant