Sorin Monolyrh Integrated Membrane Lung
FDA 510(k) K922933 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK922933
Submission
- Device name
- Sorin Monolyrh Integrated Membrane Lung
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
Irvine, CA, US - Received
- June 18, 1992
- Decision date
- November 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K931444 | Plexus 2 & 3.5 Hollow Fiber OxygenatorsDTZ · Traditional | 05/27/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | 05/18/1993SE |
| K925615 | Shiley Specialized,Pediatric & Neonatal Trach.TubeCBI · Traditional | 03/26/1993SE |
| K925369 | BCD Advanced Blood Carioplegia SystemsDTR · Traditional | 03/26/1993SE |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | 02/18/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | 02/02/1993SE |
| K854963 | S80 Implantable Cardiac Pacing LeadDTB · Traditional | 06/24/1986SE |
| K852641 | Orion 40 Cardiac Stimulator & PMP 200 ProgrammerDXY · Traditional | 01/14/1986SE |
| K851365 | Sorin Biomedica Orion 30/A Cardiac Stimulator & PMDXY · Traditional | 12/03/1985SE |
| K841948 | Testosterone Direct RadioimmunoassayCDZ · Traditional | 06/25/1984SE |
Questions and answers
When was Sorin Monolyrh Integrated Membrane Lung cleared by the FDA?
Sorin Monolyrh Integrated Membrane Lung (K922933) received a 510(k) decision of Substantially Equivalent on November 30, 1992, 165 days after the submission was received.
What is the product code of K922933?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.