The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Haemonetics Cell Saver Elite Autotransfusion System.
| Device ID | K160197 |
| 510k Number | K160197 |
| Device Name: | Haemonetics Cell Saver Elite Autotransfusion System |
| Classification | Apparatus, Autotransfusion |
| Applicant | Haemonetics Corporation 400 WOOD ROAD Braintree, MA 02184 |
| Contact | Mark Anzalone |
| Correspondent | Mark Anzalone Haemonetics Corporation 400 WOOD ROAD Braintree, MA 02184 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-05-24 |
| Summary: | summary |