FDA 510(k)

TheraSphere 360 Y-90 Management Platform

K-Number: K252547 · 2025-10-28

Decision Date2025-10-28

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TheraSphere 360 Y-90 Management Platform is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-10-28 under approval number K252547. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraSphere 360 Y-90 Management Platform?

TheraSphere 360 Y-90 Management Platform is a medical device that received FDA 510(k) clearance on 2025-10-28. It is manufactured by Boston Scientific Corporation. The 510(k) number is K252547.

When was TheraSphere 360 Y-90 Management Platform approved by the FDA?

TheraSphere 360 Y-90 Management Platform received FDA 510(k) clearance on 2025-10-28, under approval number K252547.

What company makes TheraSphere 360 Y-90 Management Platform?

TheraSphere 360 Y-90 Management Platform is manufactured by Boston Scientific Corporation.

What is the FDA product code for TheraSphere 360 Y-90 Management Platform?

The FDA product code for TheraSphere 360 Y-90 Management Platform is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.