QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
FDA 510(k) clearance K150267 · decided 2015-05-07
Clearance details
- K-number
- K150267
- Device name
- QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2015-02-04
- Decision date
- 2015-05-07
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rastatt De-Bw, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. recall (Z-1636-2023) | Maquet Medical Systems USA | 2023-05-26 |