K913177 is an FDA 510(k) clearance for the SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Solco Basle, Inc. (Hingham, US). The FDA issued a Cleared decision on February 25, 1993, 589 days after receiving the submission on July 17, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K913177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1991 |
| Decision Date | February 25, 1993 |
| Days to Decision | 589 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |