The following data is part of a premarket notification filed by Sisu Global Health with the FDA for Hemafuse System.
| Device ID | K210862 |
| 510k Number | K210862 |
| Device Name: | Hemafuse System |
| Classification | Apparatus, Autotransfusion |
| Applicant | Sisu Global Health 2720 Sisson Street Baltimore, MD 21211 |
| Contact | Gillian Henker |
| Correspondent | Adrienne Harris in2being LLC 131 E Michigan Ave Suite E Saline, MI 48176 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2021-07-29 |