QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
FDA 510(k) clearance K090689 · decided 2009-10-29
Clearance details
- K-number
- K090689
- Device name
- QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2009-03-16
- Decision date
- 2009-10-29
- Days to decision
- 227 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 Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HM recall (Z-1657-2023) | Maquet Medical Systems USA | 2023-05-30 |
| QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50 recall (Z-1637-2023) | 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 |