TheraSphere 360™ Y-90 Management Platform
FDA 510(k) clearance K262462 · decided 2026-07-24
Clearance details
- K-number
- K262462
- Device name
- TheraSphere 360™ Y-90 Management Platform
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2026-07-17
- Decision date
- 2026-07-24
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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