510(k) K183490
- Device
- Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface, Affinity NT Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Balance Biosurface
- Applicant
- Medtronic Inc
- 510(k) number
- K183490
- Product code
- DTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-12
- Date received
- 2018-12-17
- Regulation
- 870.4350
- Classification name
- Oxygenator, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Wendy Pinor
- Address
- 7611 Northland Dr. Minneapolis MN US 55428 55428
FDA Registration Numbers#
- 3030125051
- 3021599320
- 9680841
- 2184009
- 1220648
- 3008307705
- 8010762
- 2011171
- 3003752502
- 1928237
- 9617601
- 3002807090
- 3011554160
- 1319639
- 2528981
- 1218444
- 3014990448
- 1643817
- 3016746283
- 2916596
- 3013267343
- 3005941719
- 9681834
- 8010026
- 3010163695
- 3010155661
- 3002806603
- 3019807891
- 1625519
- 1124841
- 3009507273
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | 2026-03-16 |
| K240934 | 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. | 2026-03-12 |
| K250821 | 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 | 2025-12-12 |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | 2025-11-24 |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L | 2024-09-12 |
| K240666 | 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 | 2024-07-10 |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | 2024-06-12 |
| K231652 | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | 2023-11-16 |
| K231773 | 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 | 2023-11-08 |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. | 2023-11-01 |
| K230640 | Affinity Fusion™ Oxygenator System | Medtronic, Inc. | 2023-04-06 |
| K223161 | OXY-1 System | Abiomed, Inc. | 2023-02-23 |
| K222297 | CentriMag Pre-connected Pack | Abbott | 2022-12-01 |
| K212341 | 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 | 2022-01-28 |
| K203424 | 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 | 2021-12-17 |