Panels › Cardiovascular › Product code QJZ · Class 2
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Regulation 870.4100
1510(k)s in 12 months (4 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in QJZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Fresenius Medical Care Holdings, Inc. | 0 | 2 |
| Fresenius Medical Care Renal Therapies Group, LLC | 2 | 0 |
| Medtronic, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2024 | Fresenius Medical Care Holdings, Inc. Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and ph Open, Classified |
QJZ | K191407 |
| Dec 7, 2021 | Fresenius Medical Care Holdings, Inc. Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)-
Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation Open, Classified |
QJZ | K191407 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.