Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Okami Medical. It received FDA 510(k) clearance on 2019-10-30 under approval 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. It is manufactured by Okami Medical. The 510(k) number is K192083.

When was Okami Medical LOBO Vascular Occlusion System approved by the FDA?

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

What company makes Okami Medical LOBO Vascular Occlusion System?

Okami Medical LOBO Vascular Occlusion System is manufactured by Okami Medical.

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

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Okami Medical

K203025LOBO Vascular Occlusion System (model LOBO-5) K220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)

Related Devices (Code: KRD)

K162373LC Bead LUMIBiocompatibles UK Limited K160219Hilal Embolization MicroCoilsCook Incorporated K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated K150876Bead BlockBiocompatibles UK , Ltd. K171946Gel-BeadVascular Solutions, Inc. K172372QuadraSphere MicrospheresBiosphere Medical, S.A.

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.

↑