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FDA 510(k)

TheraSphere 360™ Y-90 Management Platform

K-Number: K262462 · 2026-07-24

ApplicantBoston Scientific Corporation
Decision Date2026-07-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TheraSphere 360™ Y-90 Management Platform is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K262462. 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 2026-07-24. The listed applicant is Boston Scientific Corporation. The 510(k) number is K262462.

When did TheraSphere 360™ Y-90 Management Platform receive FDA 510(k) clearance?

TheraSphere 360™ Y-90 Management Platform received FDA 510(k) clearance on 2026-07-24, under 510(k) number K262462.

Who is the listed applicant for TheraSphere 360™ Y-90 Management Platform?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

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

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