Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
FDA 510(k) clearance K201305 · decided 2021-09-03
Clearance details
- K-number
- K201305
- Device name
- Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- Applicant
- Atrium Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-05-15
- Decision date
- 2021-09-03
- Days to decision
- 476 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Merrimack, NH, US
- Third-party review
- No
- Expedited review
- No
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| Hemafuse System (K210862) | Sisu Global Health | 2021-07-29 |
| FlowSaver Blood Filter (K210176) | Inari Medical | 2021-07-22 |
| CATSmart, Automated Blood Processing Autotransfusion System (K210089) | Fresenius Kabi AG | 2021-02-11 |
| ProCell Surgical Sponge-Blood Recovery Unit (K193361) | Procell Surgical, Inc. | 2020-06-01 |
| CATSmart (K192368) | Fresenius Kabi AG | 2019-09-27 |
| CATSmart (K180831) | Fresenius Kabi AG | 2018-12-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit recall (Z-0710-2024) | Maquet Cardiovascular, LLC | 2024-01-12 |
| Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, recall (Z-0316-2024) | Atrium Medical Corporation | 2023-11-16 |
| Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; ( recall (Z-0317-2024) | Atrium Medical Corporation | 2023-11-16 |
| Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN recall (Z-0318-2024) | Atrium Medical Corporation | 2023-11-16 |