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510(k) K203025

LOBO Vascular Occlusion System (model LOBO-5) by Okami Medical — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2020
Date Received
October 2, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

Other clearances by Okami Medical

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  • K231600 — SENDERO Microcatheter (November 17, 2023)
  • K220383 — LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) (April 29, 2022)
  • K192083 — Okami Medical LOBO Vascular Occlusion System (October 30, 2019)

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  • K253376 — OBSIDIO™ Conformable Embolic (M0013972101010) (October 30, 2025)
  • K250209 — Polyvinyl Alcohol Embolic Microspheres (September 23, 2025)
  • K250133 — HARBOR Occlusion Device (July 9, 2025)
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