K920618 is an FDA 510(k) clearance for the AUTOTRANSFUSION SUCTION SET. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Lifestream Int'L, Inc. (The Woodlands, US). The FDA issued a Cleared decision on March 12, 1993, 395 days after receiving the submission on February 11, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K920618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1992 |
| Decision Date | March 12, 1993 |
| Days to Decision | 395 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 |