NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
FDA 510(k) clearance K141432 · decided 2014-07-07
Clearance details
- K-number
- K141432
- Device name
- NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2014-05-30
- Decision date
- 2014-07-07
- Days to decision
- 38 days
- Clearance type
- Special
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rastatt De-Bw, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Maquet Cardiopulmonary
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADRO recall (Z-0436-2019) | Maquet Cardiovascular Us Sales, Llc | 2018-11-28 |
| QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i recall (Z-0437-2019) | Maquet Cardiovascular Us Sales, Llc | 2018-11-28 |