K241458
- 510(k) number
- K241458
- Device name
- Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
- Applicant
- Borvo Medical, Inc. CA · US
- Product code
- JXG — Shunt, Central Nervous System And Components
- Decision date
- 2024-08-20
- Date received
- 2024-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K241458.pdf
Official FDA record: K241458
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.