Name: Predicase
Price: 199 USD

K-number	K252547
Device name	TheraSphere 360 Y-90 Management Platform
Applicant	Boston Scientific Corporation
Product code	LLZ
Device class	Class II
Decision date	Oct 28, 2025
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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TheraSphere 360 Y-90 Management Platform

Everything you need for a 510(k) submission. Nothing you don't.

TheraSphere 360 Y-90 Management Platform