QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
FDA 510(k) clearance K100278 · decided 2010-04-30
Clearance details
- K-number
- K100278
- Device name
- QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2010-02-01
- Decision date
- 2010-04-30
- Days to decision
- 88 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-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMO recall (Z-1658-2023) | Maquet Medical Systems USA | 2023-05-30 |
| Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Numbe recall (Z-0870-2015) | Maquet Cardiovascular Us Sales, Llc | 2014-12-24 |
| MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion memb recall (Z-0689-2012) | Maquet Cardiovascular Us Sales, Llc | 2012-01-11 |