K043140 is an FDA 510(k) clearance for the EXPRESS AND OASIS CHEST DRAIN. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on December 8, 2004, 23 days after receiving the submission on November 15, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K043140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2004 |
| Decision Date | December 08, 2004 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |