K191402 is an FDA 510(k) clearance for the Heater-Cooler System 3T. This device is classified as a Controller, Temperature, Cardiopulmonary Bypass (Class II - Special Controls, product code DWC).
Submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on February 25, 2020, 277 days after receiving the submission on May 24, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4250. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K191402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2019 |
| Decision Date | February 25, 2020 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWC - Controller, Temperature, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4250 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |