K201305 is an FDA 510(k) clearance for the Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Atrium Medical Corporation (Merrimack, US). The FDA issued a Cleared decision on September 3, 2021, 476 days after receiving the submission on May 15, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K201305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2020 |
| Decision Date | September 03, 2021 |
| Days to Decision | 476 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | CAC - Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |