510(k) K043582 ยท KDQ Bottle, Collection, Vacuum
OCEAN CHEST DRAIN
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, Jan 21, 2005 |
| Received | Dec 28, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2023 | Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY Open, Classified |
CAC | None listed |
| Nov 15, 2022 | Atrium Medical Corporation Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000 Open, Classified |
KDQ | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL
Model Number: 2002-000 Open, Classified |
KDQ | None listed |
| Oct 22, 2021 | Atrium Medical Corporation The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal tha Open, Classified |
KDQ | None listed |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Ocean Water Seal Chest Drain, Single Collection WAC
Reference: 2002-000
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion a Terminated |
KDQ | None listed |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Ocean Water Seal Chest Drain, Single Collection w/AC
Reference: 2002-100
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion Terminated |
KDQ | None listed |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S
Reference: 2002-300
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and r Terminated |
KDQ | None listed |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE
Reference: 2002-400
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and rest Terminated |
KDQ | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.