510(k) K200683
- Device
- INSPIRE 7FM Hollow Fiber Oxygenator With Integrated Arterial Filter, INSPIRE 7F Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir, INSPIRE 7F DUAL Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Res
- Applicant
- Sorin Group Italia S.R.L.
- 510(k) number
- K200683
- Product code
- DTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-06-12
- Date received
- 2020-03-16
- Regulation
- 870.4350
- Classification name
- Oxygenator, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Luigi Vecchi
- Address
- Via Statale 12 Nord, 86 Mirandola IT 41037 41037
FDA Registration Numbers#
- 3010155661
- 9617601
- 2528981
- 2916596
- 9681834
- 3010163695
- 3016746283
- 3008307705
- 3002806603
- 1625519
- 1220648
- 3019807891
- 3009507273
- 3011554160
- 3021599320
- 3003752502
- 2184009
- 3014990448
- 1643817
- 3005941719
- 2011171
- 1124841
- 1218444
- 1319639
- 3030125051
- 9680841
- 8010026
- 1928237
- 3013267343
- 3002807090
- 8010762
Source Documents#
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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases