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FDA 510(k)

Okami Medical LOBO Vascular Occlusion System

K-Number: K192083 · 2019-10-30

ApplicantOkami Medical
Decision Date2019-10-30
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Okami Medical LOBO Vascular Occlusion System is the device name listed in this FDA 510(k) record. The listed applicant is Okami Medical. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K192083. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Okami Medical LOBO Vascular Occlusion System?

Okami Medical LOBO Vascular Occlusion System is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Okami Medical. The 510(k) number is K192083.

When did Okami Medical LOBO Vascular Occlusion System receive FDA 510(k) clearance?

Okami Medical LOBO Vascular Occlusion System received FDA 510(k) clearance on 2019-10-30, under 510(k) number K192083.

Who is the listed applicant for Okami Medical LOBO Vascular Occlusion System?

The FDA 510(k) record lists Okami Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Okami Medical LOBO Vascular Occlusion System?

The FDA product code for Okami Medical LOBO Vascular Occlusion System is KRD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07525518Okami Medical ALPHA RegistryENROLLING_BY_INVITATION

Other records listing Okami Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260508LOBO Vascular Occlusion SystemK242644SENDERO MAX Delivery CatheterK240384SENDERO MicrocatheterK231600SENDERO MicrocatheterK220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)K203025LOBO Vascular Occlusion System (model LOBO-5)

View all 7 devices →

Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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