K103202 is an FDA 510(k) clearance for the PREASSEMBLED SURGICAL WASH SET. 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 November 23, 2010, 22 days after receiving the submission on November 1, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K103202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2010 |
| Decision Date | November 23, 2010 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |