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FDA 510(k)

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)

K-Number: K220383 · 2022-04-29

ApplicantOkami Medical
Decision Date2022-04-29
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) is a medical device manufactured by Okami Medical. It received FDA 510(k) clearance on 2022-04-29 under approval number K220383. 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 (models LOBO-7 and LOBO-9)?

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Okami Medical. The 510(k) number is K220383.

When was LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) approved by the FDA?

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) received FDA 510(k) clearance on 2022-04-29, under approval number K220383.

What company makes LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)?

LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) is manufactured by Okami Medical.

What is the FDA product code for LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)?

The FDA product code for LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) is KRD.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System 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 NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED

Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) 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 K203025LOBO Vascular Occlusion System (model LOBO-5)

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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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