K160197 is an FDA 510(k) clearance for the Haemonetics Cell Saver Elite Autotransfusion System. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Haemonetics Corporation (Braintree, US). The FDA issued a Cleared decision on May 24, 2016, 118 days after receiving the submission on January 27, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K160197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2016 |
| Decision Date | May 24, 2016 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |