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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K261335 | VitalFlow Set with Balance Biosurface Medtronic, Inc. | QJZ |
| Sep 12, 2024 | K240880 | VitalFlow Set with Balance Biosurface Medtronic, Inc. | QJZ |
| Apr 15, 2024 | K232926 | Novalung ultimate kit (US) Fresenius Medical Care Renal Therapies Group, LLC | QJZ |
| Feb 21, 2020 | K191407 | Novalung System Fresenius Medical Care Renal Therapies Group, LLC | QJZ |
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