QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
FDA 510(k) clearance K102464 · decided 2011-03-04
Clearance details
- K-number
- K102464
- Device name
- QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2010-08-27
- Decision date
- 2011-03-04
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hirrlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 1000 recall (Z-1660-2023) | Maquet Medical Systems USA | 2023-05-30 |
| QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 1000 recall (Z-1640-2023) | Maquet Medical Systems USA | 2023-05-26 |
| QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADRO recall (Z-0436-2019) | Maquet Cardiovascular Us Sales, Llc | 2018-11-28 |
| QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i recall (Z-0437-2019) | Maquet Cardiovascular Us Sales, Llc | 2018-11-28 |