K931552 is an FDA 510(k) clearance for the DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on October 8, 1993, 193 days after receiving the submission on March 29, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K931552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1993 |
| Decision Date | October 08, 1993 |
| Days to Decision | 193 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 |