K223168 is an FDA 510(k) clearance for the Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface. This device is classified as a Tubing, Long Term Support Greater Than 6 Hours (Class II - Special Controls, product code QWF).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on April 19, 2023, 190 days after receiving the submission on October 11, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100. The Tubing And Accessories Are Intended To Connect Perfusion Devices And Circulate Blood As Part Of Extracorporeal Membrane Oxygenation Lasting Longer Than 6 Hours..
| 510(k) Number | K223168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2022 |
| Decision Date | April 19, 2023 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QWF — Tubing, Long Term Support Greater Than 6 Hours |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4100 |
| Definition | The Tubing And Accessories Are Intended To Connect Perfusion Devices And Circulate Blood As Part Of Extracorporeal Membrane Oxygenation Lasting Longer Than 6 Hours. |