K240584 is an FDA 510(k) clearance for the XTRA Autotransfusion System (with XTRA Bowl sets). This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Sorin Group Italia S.R.L. (Mirandola ( Modena), IT). The FDA issued a Cleared decision on April 29, 2024, 59 days after receiving the submission on March 1, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K240584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2024 |
| Decision Date | April 29, 2024 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |