Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

FDA 510(k) K212057 · Artventive Medical Group, Inc.

Substantially Equivalent

510(k) numberK212057

Submission

Device name
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
Applicant
Artventive Medical Group, Inc.
San Marcos, CA, US
Received
July 1, 2021
Decision date
March 1, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRD – Device, Vascular, For Promoting Embolization
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3300
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code KRD

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K252812UniPearls® Embolic MicrospheresKRD · Traditional Suzhou Haowei Medical Technology Co., Ltd.07/31/2026SE
K261488OBSIDIO Conformable EmbolicKRD · Traditional Boston Scientific Corporation07/24/2026SE
K261866Concerto Versa™ Detachable CoilKRD · Special Medtronic, Inc.06/24/2026SE
K260635HARBOR Occlusion DeviceKRD · Traditional Nuvascular, Inc.06/12/2026SE
K260508LOBO Vascular Occlusion SystemKRD · Traditional Okami Medical, Inc.04/10/2026SE
K253511Concerto Versa™ Detachable CoilKRD · Traditional Medtronic, Inc.01/14/2026SE
K253677Tembo Embolic SystemKRD · Special Instylla, Inc.12/15/2025SE
K253376OBSIDIO™ Conformable Embolic (M0013972101010)KRD · Special Boston Scientific Corporation10/30/2025SE
K250209Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional Canyon Medical, Inc.09/23/2025SE
K250133HARBOR Occlusion DeviceKRD · Traditional Nuvascular, Inc.07/09/2025SE

More from Nuvascular, Inc.

510(k)DeviceDecision
K150402Endoluminal Occlusion System-EOSKRD · Traditional 09/25/2015SE
K133924Endoluminal Occlusion System (Eos)KRD · Abbreviated 12/03/2014SE

Questions and answers

When was Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS cleared by the FDA?

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS (K212057) received a 510(k) decision of Substantially Equivalent on March 1, 2022, 243 days after the submission was received.

What is the product code of K212057?

The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.