Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate
FDA 510(k) K130433 · Sorin Group Italia S.R.L.
510(k) numberK130433
Submission
- Device name
- Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate
- Applicant
- Sorin Group Italia S.R.L.
Arvada, CO, US - Received
- February 21, 2013
- Decision date
- March 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4350
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane OxygenatorDTZ · Traditional | Lifemotion Medical Technology Co., Ltd. | 03/16/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional | Eurosets S.R.L | 12/12/2025SE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional | Eurosets S.R.L | 11/24/2025SE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | Qura S.R.L | 09/12/2024SE |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | Medtronic Perfusion Systems | 07/10/2024SE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special | Medtronic, Inc. | 06/12/2024SE |
| K231652 | D100 Kids; D101 KidsDTZ · Special | Sorin Group Italia S.R.L. | 11/16/2023SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional | Chalice Medical , Ltd. | 11/01/2023SE |
More from Chalice Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253671 | Dual Stage Venous CannulaeDWF · Traditional | 01/30/2026SE |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional | 12/22/2025SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | 12/19/2025SE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special | 06/27/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | 05/30/2025SE |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14…KDI · Traditional | 04/25/2025SE |
| K242953 | KIDS Arterial FiltersDTM · Special | 12/20/2024SE |
| K242092 | MICRO Arterial FiltersDTM · Special | 11/18/2024SE |
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | 08/16/2024SE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | 04/29/2024SE |
Questions and answers
When was Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate cleared by the FDA?
Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate (K130433) received a 510(k) decision of Substantially Equivalent on March 20, 2013, 27 days after the submission was received.
What is the product code of K130433?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.