K191407 is an FDA 510(k) clearance for the Novalung System. This device is classified as a Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure (Class II - Special Controls, product code QJZ).
Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on February 21, 2020, 269 days after receiving the submission on May 28, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100. Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure..
| 510(k) Number | K191407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2019 |
| Decision Date | February 21, 2020 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QJZ — Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4100 |
| Definition | Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure. |