QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
FDA 510(k) clearance K093522 · decided 2009-12-07
Clearance details
- K-number
- K093522
- Device name
- QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2009-11-13
- Decision date
- 2009-12-07
- Days to decision
- 24 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 |
|---|---|---|
| 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 |