DTZ — Oxygenator, Cardiopulmonary Bypass Class II
FDA Device Classification
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 |
|---|
| 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 |
| K201642 | chalice medical | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | September 18, 2020 |