LOBO Vascular Occlusion System— 510(k) K262798
Substantially EquivalentOkami Medical, Inc.
FDA 510(k) clearance K262798 for LOBO Vascular Occlusion System, Substantially Equivalent on 2026-10-06. Applicant: Okami Medical, Inc.. Device class: 2.
Summary
Okami Medical's LOBO Vascular Occlusion System is filed under KRD, vascular devices for promoting embolization. The record doesn't describe the system's components or sizes.
Class II, 21 CFR 870.3300. The Cardiovascular panel reviewed it as a Traditional 510(k).
Okami Medical filed from Aliso Viejo, California. Review took 60 days (August 7 to October 6, 2026).
Clearance details
- Applicant
- Okami Medical, Inc.
- Product code
- Product code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Recent devices under product code KRD
view allMore clearances from Okami Medical, Inc.
view allAdverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.