QJZ — Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure Class II
Classification Details
- Product Code
- QJZ
- Device Class
- Class II
- Regulation Number
- 870.4100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240880 | medtronic | VitalFlow Set with Balance Biosurface | September 12, 2024 |
| K232926 | fresenius medical care renal therapies group | Novalung ultimate kit (US) | April 15, 2024 |
| K191407 | fresenius medical care renal therapies group | Novalung System | February 21, 2020 |