510(k) K043140 ยท CAC Apparatus, Autotransfusion
EXPRESS AND OASIS CHEST DRAIN
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, Dec 8, 2004 |
| Received | Nov 15, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043140
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2024 | Maquet Cardiovascular, LLC Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Open, Classified |
CAC | None listed |
| Dec 28, 2023 | Atrium Medical Corporation Atrium Oasis Drain Single W / AC, Part No. 3600-100 Open, Classified |
CAC | None listed |
| Dec 2, 2023 | Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION. Open, Classified |
KDQ | 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 |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC
Reference: 3600-100
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung Terminated |
CAC | None listed |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC
Reference: 4000-100N
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung ex Terminated |
CAC | None listed |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC
Reference: 3612-100
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion a Terminated |
CAC | None listed |
| Jun 29, 2015 | Atrium Medical Corporation Ocean Water Seal Chest Drain, Single Collection W/AC,
P/N: 2002-000 Terminated |
PAD | None listed |
| Jun 29, 2015 | Atrium Medical Corporation Ocean Water Seal Chest Drain, SINGLE W/AC
P/N: 2002-100 Terminated |
PAD | None listed |
| Jun 29, 2015 | Atrium Medical Corporation Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC
P/N: 3600-100 Terminated |
PAD | None listed |
| Jun 29, 2015 | Atrium Medical Corporation EXPRESS Dry Seal Chest Drain, Single Collection
P/N: 4000-100N Terminated |
PAD | None listed |
| Jul 1, 2014 | Atrium Medical Corporation Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N.
Autotransfusion Apparatus. Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000.
To evacuate air and/or fluid from the chest cavity or me Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging
Product Code: 2050-070.
To evacuate air and/or fluid from the chest Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300.
To evacuate air and/or fluid from the chest cavity or medi Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors
Product Code: 2052-000.
To evacuate air and/or fluid from the Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300.
To evacuate air and/or fluid from the chest cavity or medi Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100.
To evacuate air and/or fluid from the chest cavity or med Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100.
To evacuate air and/or fluid from the chest cavity or medias Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N.
To evacuate air and/or fluid from the chest cavity or mediastinum. Terminated |
CAC | None listed |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P.
To evacuate air and/or fluid from the chest cavity or medi Terminated |
CAC | None listed |
| Feb 15, 2007 | Atrium Medical Corporation Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package
Model Number: 4050-170N Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.