K893578 is an FDA 510(k) clearance for the PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on August 1, 1989, 84 days after receiving the submission on May 9, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K893578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1989 |
| Decision Date | August 01, 1989 |
| Days to Decision | 84 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 |