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Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

by Eurosets S.R.L.

510(k) K242503

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242503 Date24 Nov 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTZ
FDA applicant
Eurosets S.R.L
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is a cardiopulmonary bypass oxygenator classified under product code DTZ and regulation number 870.4350. It is designed for pediatric use and includes an integrated arterial filter as part of its oxygenator module.

The device is supplied non-sterile and intended for single-use. It has received FDA 510(k) clearance (K242503) as substantially equivalent to a predicate device, with cardiovascular advisory committee review. Performance specifications include a flow range of 0.5 lpm to 3.5 lpm and a priming volume of 130 ml including the arterial filter.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Trilly Pediatric Oxygenator with Integrated Arterial Filter used for?

    The Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) is designed for pediatric cardiopulmonary bypass procedures. It serves as an oxygenator with an integrated arterial filter module to facilitate gas exchange during cardiac surgery in pediatric patients.

  • How is the Trilly Pediatric Oxygenator supplied and is it reusable?

    The device is supplied non-sterile and is intended for single-use only. After use, it should not be reused or resterilized due to potential risks of contamination or device failure.

  • What are the performance specifications of the Trilly Pediatric Oxygenator?

    The Trilly Pediatric Oxygenator has a flow range of 0.5 liters per minute to 3.5 liters per minute and a priming volume of 130 ml, which includes the integrated arterial filter component. These specifications are optimized for pediatric patient requirements during cardiopulmonary bypass procedures.

  • What is the regulatory status of the Trilly Pediatric Oxygenator?

    The device has received FDA 510(k) clearance (K242503) as substantially equivalent to a predicate device. It underwent review by the Cardiovascular advisory committee and is classified under product code DTZ with regulation number 870.4350.