K101586 is an FDA 510(k) clearance for the XTRA AUTOTRANSFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on October 5, 2010, 120 days after receiving the submission on June 7, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K101586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2010 |
| Decision Date | October 05, 2010 |
| Days to Decision | 120 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 |