QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
FDA 510(k) clearance K132829 · decided 2013-10-08
Clearance details
- K-number
- K132829
- Device name
- QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2013-09-09
- Decision date
- 2013-10-08
- 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
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusi recall (Z-1689-2015) | Maquet Cardiovascular Us Sales, Llc | 2015-05-28 |