K900483 is an FDA 510(k) clearance for the VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on August 29, 1990, 209 days after receiving the submission on February 1, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K900483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1990 |
| Decision Date | August 29, 1990 |
| Days to Decision | 209 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 |