The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for Stockert S5 System.
| Device ID | K210130 |
| 510k Number | K210130 |
| Device Name: | Stockert S5 System |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | LivaNova Deutschland GmbH Lindberghstr. 25 Munich, DE 80939 |
| Contact | Florian Goetz |
| Correspondent | Florian Goetz LivaNova Deutschland GmbH Lindberghstr. 25 Munich, DE 80939 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817902775 | K210130 | 000 |
| 04033817902645 | K210130 | 000 |
| 04033817902621 | K210130 | 000 |
| 04033817902614 | K210130 | 000 |
| 04033817902607 | K210130 | 000 |
| 04033817902591 | K210130 | 000 |
| 04033817902577 | K210130 | 000 |
| 04033817902386 | K210130 | 000 |
| 04033817902379 | K210130 | 000 |
| 04033817902669 | K210130 | 000 |
| 04033817902676 | K210130 | 000 |
| 04033817902683 | K210130 | 000 |
| 04033817902768 | K210130 | 000 |
| 04033817902751 | K210130 | 000 |
| 04033817902744 | K210130 | 000 |
| 04033817902737 | K210130 | 000 |
| 04033817902720 | K210130 | 000 |
| 04033817902713 | K210130 | 000 |
| 04033817902706 | K210130 | 000 |
| 04033817902690 | K210130 | 000 |
| 04033817903123 | K210130 | 000 |