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FDA 510(k)

LOBO Vascular Occlusion System (model LOBO-5)

K-Number: K203025 · 2020-11-05

ApplicantOkami Medical
Decision Date2020-11-05
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOBO Vascular Occlusion System (model LOBO-5) is the device name listed in this FDA 510(k) record. The listed applicant is Okami Medical. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K203025. 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 LOBO Vascular Occlusion System (model LOBO-5)?

LOBO Vascular Occlusion System (model LOBO-5) is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Okami Medical. The 510(k) number is K203025.

When did LOBO Vascular Occlusion System (model LOBO-5) receive FDA 510(k) clearance?

LOBO Vascular Occlusion System (model LOBO-5) received FDA 510(k) clearance on 2020-11-05, under 510(k) number K203025.

Who is the listed applicant for LOBO Vascular Occlusion System (model LOBO-5)?

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 LOBO Vascular Occlusion System (model LOBO-5)?

The FDA product code for LOBO Vascular Occlusion System (model LOBO-5) 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)K192083Okami Medical LOBO Vascular Occlusion System

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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