The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for Heater-cooler System 3t.
| Device ID | K220635 |
| 510k Number | K220635 |
| Device Name: | Heater-Cooler System 3T |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | LivaNova Deutschland GmbH Lindbergh Strasse 25 Munchen, DE 80939 |
| Contact | Julia E. Leslie |
| Correspondent | Julia E. Leslie LivaNova Deutschland GmbH Lindbergh Strasse 25 Munchen, DE 80939 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-11-16 |