K233702 is an FDA 510(k) clearance for the SMARxT Tubing and Connectors. This device is classified as a Tubing, Pump, Cardiopulmonary Bypass (Class II - Special Controls, product code DWE).
Submitted by LivaNova USA, Inc. (Arvada, US). The FDA issued a Cleared decision on August 8, 2024, 265 days after receiving the submission on November 17, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4390.
| 510(k) Number | K233702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2023 |
| Decision Date | August 08, 2024 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWE — Tubing, Pump, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4390 |