NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
FDA 510(k) clearance K102919 · decided 2011-03-11
Clearance details
- K-number
- K102919
- Device name
- NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2010-10-01
- Decision date
- 2011-03-11
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- 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 |
|---|---|---|
| Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. V recall (Z-1661-2023) | Maquet Medical Systems USA | 2023-05-30 |
| Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. V recall (Z-1642-2023) | Maquet Medical Systems USA | 2023-05-26 |