QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
FDA 510(k) clearance K101153 · decided 2010-12-08
Clearance details
- K-number
- K101153
- Device name
- QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2010-04-23
- Decision date
- 2010-12-08
- Days to decision
- 229 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 Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000- recall (Z-1656-2023) | Maquet Medical Systems USA | 2023-05-30 |
| HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 70 recall (Z-1634-2023) | Maquet Medical Systems USA | 2023-05-26 |
| BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 70106 recall (Z-1635-2023) | Maquet Medical Systems USA | 2023-05-26 |