QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
FDA 510(k) clearance K103191 · decided 2011-03-08
Clearance details
- K-number
- K103191
- Device name
- QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2010-10-28
- Decision date
- 2011-03-08
- Days to decision
- 131 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 Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3000 recall (Z-1655-2023) | Maquet Medical Systems USA | 2023-05-30 |
| QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3000 recall (Z-1641-2023) | Maquet Medical Systems USA | 2023-05-26 |
| QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; recall (Z-2262-2013) | Maquet Cardiovascular Us Sales, Llc | 2013-09-20 |
| QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; recall (Z-0160-2013) | Maquet Cardiovascular Us Sales, Llc | 2012-10-26 |