K872927 is an FDA 510(k) clearance for the DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 9, 1987, 74 days after receiving the submission on July 27, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K872927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1987 |
| Decision Date | October 09, 1987 |
| Days to Decision | 74 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 |