Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4350](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4350) → DTZ — Oxygenator, Cardiopulmonary Bypass # DTZ · Oxygenator, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4350 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ ## Overview - **Product Code:** DTZ - **Device Name:** Oxygenator, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4350](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4350) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. ## Classification Rationale Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.” ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.” ## Recent Cleared Devices (20 of 254) Showing 20 most recent of 254 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253838](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K253838.md) | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | Mar 16, 2026 | SESE | | [K240934](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K240934.md) | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical S.R.L. | Mar 12, 2026 | SESE | | [K250821](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K250821.md) | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L | Dec 12, 2025 | SESE | | [K242503](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K242503.md) | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | Nov 24, 2025 | SESE | | [K231982](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K231982.md) | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L | Sep 12, 2024 | SESE | | [K240666](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K240666.md) | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | Medtronic Perfusion Systems | Jul 10, 2024 | SESE | | [K241352](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K241352.md) | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | Jun 12, 2024 | SESE | | [K231652](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K231652.md) | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | Nov 16, 2023 | SESE | | [K231773](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K231773.md) | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Qura S.R.L | Nov 8, 2023 | SESE | | [K231414](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K231414.md) | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. | Nov 1, 2023 | SESE | | [K230640](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K230640.md) | Affinity Fusion™ Oxygenator System | Medtronic, Inc. | Apr 6, 2023 | SESE | | [K223161](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K223161.md) | OXY-1 System | Abiomed, Inc. | Feb 23, 2023 | SESE | | [K222297](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K222297.md) | CentriMag Pre-connected Pack | Abbott | Dec 1, 2022 | SESE | | [K212341](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K212341.md) | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | Qura S.R.L | Jan 28, 2022 | SESE | | [K203424](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K203424.md) | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | Qura S.R.L | Dec 17, 2021 | SESE | | [K202510](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K202510.md) | AMG PMP Infant | Eurosets S.R.L | Dec 10, 2021 | SESE | | [K203111](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K203111.md) | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Medtronic | Sep 16, 2021 | SESE | | [K211495](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K211495.md) | EOS PMP | Sorin Group Italia S.R.L. | Jul 12, 2021 | SESE | | [K202206](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K202206.md) | AMG PMP Pediatric | Eurosets S.R.L | Apr 1, 2021 | SESE | | [K200109](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K200109.md) | OXY-1 System | Abiomed, Inc. | Oct 23, 2020 | SESE | ## Top Applicants - Sorin Group Italia S.R.L. — 22 clearances - Medtronic, Inc. — 15 clearances - Maquet Cardiopulmonary, AG — 13 clearances - American Bentley — 13 clearances - Medtronic Vascular — 12 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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