QJZ
- Product code
- QJZ
- Device name
- Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4100
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 4 (all years; only the last 3 years are listed here)
FDA classification definition
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261335 | 2026-07-31 | Medtronic, Inc. | VitalFlow Set with Balance Biosurface | FDA |
| K240880 | 2024-09-12 | Medtronic, Inc. | VitalFlow Set with Balance Biosurface | |
| K232926 | 2024-04-15 | Fresenius Medical Care Renal Therapies… | Novalung ultimate kit (US) |
Official FDA classification page: QJZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).