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FDA 510(k)

LOBO Vascular Occlusion System

K-Number: K260508 · 2026-04-10

ApplicantOkami Medical, Inc.
Decision Date2026-04-10
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOBO Vascular Occlusion System is a medical device manufactured by Okami Medical, Inc.. It received FDA 510(k) clearance on 2026-04-10 under approval number K260508. 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?

LOBO Vascular Occlusion System is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Okami Medical, Inc.. The 510(k) number is K260508.

When was LOBO Vascular Occlusion System approved by the FDA?

LOBO Vascular Occlusion System received FDA 510(k) clearance on 2026-04-10, under approval number K260508.

What company makes LOBO Vascular Occlusion System?

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

What is the FDA product code for LOBO Vascular Occlusion System?

The FDA product code for LOBO Vascular Occlusion System 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: 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, Inc.

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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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