510(k) K191407 ยท QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Novalung System
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | May 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191407
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.