510(k) K201305 ยท CAC Apparatus, Autotransfusion
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, Merrimack NH, US |
| Decision | Substantially Equivalent, Sep 3, 2021 |
| Received | May 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201305
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2024 | Maquet Cardiovascular, LLC Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Open, Classified |
CAC | None listed |
| Nov 16, 2023 | Atrium Medical Corporation Ocean Water Seal Chest Drains (Ocean):
Products REF Number Product Name
(1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;
(2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;
(3)2002-100 DRAIN, OCEAN SINGLE W/AC; Open, Classified |
CAC | None listed |
| Nov 16, 2023 | Atrium Medical Corporation Oasis Dry Suction Water Seal Chest Drains (Oasis):
(1)3600-100 DRAIN, OASIS SINGLE W/AC;
(2)3612-100 DRAIN, OASIS PEDI A/C;
(3)3650-100 DRAIN, OASIS BRU W/AC; Open, Classified |
CAC | None listed |
| Nov 16, 2023 | Atrium Medical Corporation Express Dry Seal Chest Drains (Express):
4000-100N DRAIN, EXPRESS, SINGLE;
4050-100N DRAIN, EXPRESS, BRU Open, Classified |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.