Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
K-Number: K242503 · 2025-11-24
ApplicantEurosets S.R.L
Decision Date2025-11-24
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is a medical device manufactured by Eurosets S.R.L. It received FDA 510(k) clearance on 2025-11-24 under approval number K242503. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is a medical device that received FDA 510(k) clearance on 2025-11-24. It is manufactured by Eurosets S.R.L. The 510(k) number is K242503.
When was Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) approved by the FDA?
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) received FDA 510(k) clearance on 2025-11-24, under approval number K242503.
What company makes Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is manufactured by Eurosets S.R.L.
What is the FDA product code for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)?
The FDA product code for Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is DTZ.
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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.