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)

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 a medical device manufactured by Okami Medical. It received FDA 510(k) clearance on 2020-11-05 under approval 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. It is manufactured by Okami Medical. The 510(k) number is K203025.

When was LOBO Vascular Occlusion System (model LOBO-5) approved by the FDA?

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

What company makes LOBO Vascular Occlusion System (model LOBO-5)?

LOBO Vascular Occlusion System (model LOBO-5) is manufactured by Okami Medical.

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Okami Medical

K192083Okami Medical LOBO Vascular Occlusion System 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.

↑