FDA Product Code
FDA Product Code QJZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4100
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261335 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2026-07-31 | Traditional | PDF ↗ |
| K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2024-09-12 | Traditional | PDF ↗ |
| K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 | Traditional | PDF ↗ |
| K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 | Traditional | PDF ↗ |
Product code QJZ · Class II · Cardiovascular. Data: openFDA.