TheraSphere 360 Y-90 Management Platform— 510(k) K260479
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K260479 for TheraSphere 360 Y-90 Management Platform, Substantially Equivalent on 2026-03-13. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marborough, MA, US
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.