K852736 is an FDA 510(k) clearance for the BAYLOR RAPID AUTOTRANSFUSION SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Cardio Systems, Inc. (The Woodlands, US). The FDA issued a Cleared decision on September 18, 1985, 133 days after receiving the submission on May 8, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K852736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1985 |
| Decision Date | September 18, 1985 |
| Days to Decision | 133 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 |