Name: Predicase
Price: 199 USD

K-number	K242503
Device name	Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
Applicant	Eurosets S.R.L
Product code	DTZ
Device class	Class II
Decision date	Nov 24, 2025
Decision	Substantially Equivalent
Regulation	870.4350

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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Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

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