DTZ — Oxygenator, Cardiopulmonary Bypass Class II
FDA product code DTZ covers "Oxygenator, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4350. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTZ
- Device Class
- Class II
- Regulation Number
- 870.4350
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253838 | lifemotion medical technology co | Lifemotion Disposable Membrane Oxygenator | March 16, 2026 |
| K240934 | spectrum medical | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Bl | March 12, 2026 |
| K250821 | eurosets | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) | December 12, 2025 |
| K242503 | eurosets | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | November 24, 2025 |
| K231982 | qura | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator V | September 12, 2024 |
| K240666 | medtronic perfusion systems | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac | July 10, 2024 |
| K241352 | medtronic | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity | June 12, 2024 |
| K231652 | sorin group italia | D100 KIDS; D101 KIDS | November 16, 2023 |
| K231773 | qura | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quant | November 8, 2023 |
| K231414 | chalice medical | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | November 1, 2023 |
| K230640 | medtronic | Affinity Fusion Oxygenator System | April 6, 2023 |
| K223161 | abiomed | OXY-1 System | February 23, 2023 |
| K222297 | abbott | CentriMag Pre-connected Pack | December 1, 2022 |
| K212341 | qura | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quan | January 28, 2022 |
| K203424 | qura | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygena | December 17, 2021 |
| K202510 | eurosets | AMG PMP Infant | December 10, 2021 |
| K203111 | medtronic | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | September 16, 2021 |
| K211495 | sorin group italia | EOS PMP | July 12, 2021 |
| K202206 | eurosets | AMG PMP Pediatric | April 1, 2021 |
| K200109 | abiomed | OXY-1 System | October 23, 2020 |