DTZ
- Product code
- DTZ
- Device name
- Oxygenator, Cardiopulmonary Bypass
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4350
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 254 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253838 | 2026-03-16 | Lifemotion Medical Technology Co., Ltd… | Lifemotion Disposable Membrane Oxygenator | |
| K240934 | 2026-03-12 | Spectrum Medical S.R.L. | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT1… | FDA |
| K250821 | 2025-12-12 | Eurosets S.R.L | Horizon AF Plus System (Integrated A.L. One AF Plus … | |
| K242503 | 2025-11-24 | Eurosets S.R.L | Trilly Pediatric Oxygenator with Integrated Arterial… | |
| K231982 | 2024-09-12 | Qura S.R.L | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum … | |
| K240666 | 2024-07-10 | Medtronic Perfusion Systems | Affinity Fusion Oxygenator with Integrated Arterial … | |
| K241352 | 2024-06-12 | Medtronic, Inc. | Affinity NT Oxygenator and Uncoated Cardiotomy/ Veno… | |
| K231652 | 2023-11-16 | Sorin Group Italia S.R.L. | D100 KIDS; D101 KIDS | |
| K231773 | 2023-11-08 | Qura S.R.L | Quantum Perfusion Blood Oxygenator with Integrated A… | |
| K231414 | 2023-11-01 | Chalice Medical , Ltd. | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: C… |
Official FDA classification page: DTZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).