QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
FDA 510(k) clearance K112360 · decided 2011-09-15
Clearance details
- K-number
- K112360
- Device name
- QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2011-08-17
- Decision date
- 2011-09-15
- Days to decision
- 29 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Use recall (Z-1076-2024) | Maquet Medical Systems USA | 2024-02-13 |
| BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the recall (Z-1077-2024) | Maquet Medical Systems USA | 2024-02-13 |
| BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set recall (Z-1188-2023) | Maquet Medical Systems USA | 2023-02-28 |
| 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 |