LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)— 510(k) K220383

Name: FDA 510(k) clearance K220383
Creator: U.S. Food and Drug Administration
Published: 2022-04-29

Substantially Equivalent

Okami Medical

FDA 510(k) clearance K220383 for LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9), Substantially Equivalent on 2022-04-29. Applicant: Okami Medical. Device class: 2.

Clearance details

Applicant: Okami Medical
Product code: Code KRD
Device class: Class 2
Regulation: 21 CFR 870.3300
Advisory panel: Cardiovascular
Date received: 2022-02-10
Decision date: 2022-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.