The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Catsmart, Automated Blood Processing Autotransfusion System.
| Device ID | K210089 |
| 510k Number | K210089 |
| Device Name: | CATSmart, Automated Blood Processing Autotransfusion System |
| Classification | Apparatus, Autotransfusion |
| Applicant | Fresenius Kabi AG Bad Homburg, DE 61346 |
| Contact | Deepak Mehta |
| Correspondent | Cheryl Chamberlain Roscher Fresenius Kabi Three Corporate Drive Lake Zurich, IL 60047 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-13 |
| Decision Date | 2021-02-11 |