LOBO Vascular Occlusion System— 510(k) K260508
Substantially EquivalentOkami Medical, Inc.
FDA 510(k) clearance K260508 for LOBO Vascular Occlusion System, Substantially Equivalent on 2026-04-10. Applicant: Okami Medical, Inc..
Summary
The LOBO Vascular Occlusion System is a peripheral vascular-occlusion device. Product code KRD covers vascular plugs and occlusion systems — used to close off vessels during embolization procedures, aneurysm treatment, or access-site closure. Okami Medical's LOBO line is a newer entrant in a space historically dominated by Medtronic, Abbott, and Boston Scientific.
Cardiovascular panel, Traditional 510(k). The "LOBO" naming is consistent across Okami's prior filings, suggesting this is a variant or size addition within an existing platform.
Okami Medical, Inc. files from Aliso Viejo, CA. Roughly two-month review clock — short for the cardiovascular panel, indicating a straightforward predicate comparison.
Clearance details
- Applicant
- Okami Medical, Inc.
- Product code
- Code KRD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Adverse 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.