K131553 is an FDA 510(k) clearance for the XTRA. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Sorin Group Deutschland GmbH (Waltham, US). The FDA issued a Cleared decision on March 21, 2014, 295 days after receiving the submission on May 30, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K131553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2013 |
| Decision Date | March 21, 2014 |
| Days to Decision | 295 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 |