K872590 is an FDA 510(k) clearance for the SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Solco Basle, Inc. (Rockland, US). The FDA issued a Cleared decision on September 4, 1987, 65 days after receiving the submission on July 1, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K872590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1987 |
| Decision Date | September 04, 1987 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |