Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000
FDA 510(k) K090689 · Maquet Cardiopulmonary, AG
510(k) numberK090689
Submission
- Device name
- Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000
- Applicant
- Maquet Cardiopulmonary, AG
Hirrlingen, DE - Received
- March 16, 2009
- Decision date
- October 29, 2009
- 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 |
|---|---|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsDTZ · Traditional | 05/07/2015SE |
| K140569 | Antegrade Cardioplegia Cannula(N-Type)DWF · Traditional | 11/19/2014SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | 07/07/2014SE |
| K133598 | Cardiohelp SystemDTQ · Traditional | 05/21/2014SE |
| K133265 | Quadrox-Ir Adult and Small AdultKFM · Special | 11/12/2013SE |
| K132166 | Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with…DTN · Special | 10/30/2013SE |
| K132829 | Quadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsDTZ · Special | 10/08/2013SE |
| K131666 | Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingDWF · Special | 07/05/2013SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | 07/01/2013SE |
| K123288 | HemoconcentratorKDI · Traditional | 06/26/2013SE |
Questions and answers
When was Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000 cleared by the FDA?
Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000 (K090689) received a 510(k) decision of Substantially Equivalent on October 29, 2009, 227 days after the submission was received.
What is the product code of K090689?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.