K240880 is an FDA 510(k) clearance for the VitalFlow Set with Balance Biosurface. This device is classified as a Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure (Class II - Special Controls, product code QJZ).
Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 12, 2024, 164 days after receiving the submission on April 1, 2024.
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 | K240880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2024 |
| Decision Date | September 12, 2024 |
| Days to Decision | 164 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. |