K232926 is an FDA 510(k) clearance for the Novalung ultimate kit (US). 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 April 15, 2024, 208 days after receiving the submission on September 20, 2023.
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 | K232926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2023 |
| Decision Date | April 15, 2024 |
| Days to Decision | 208 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. |