ClearanceBrief
510(k) K043140 ยท CAC Apparatus, Autotransfusion

EXPRESS AND OASIS CHEST DRAIN

ApplicantAtrium Medical Corp., Hudson NH, US
DecisionSubstantially Equivalent, Dec 8, 2004
ReceivedNov 15, 2004
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K043140

DateFirm and productCodeLinked 510(k)
Jan 12, 2024Maquet Cardiovascular, LLC
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Open, Classified
CACNone listed
Dec 28, 2023Atrium Medical Corporation
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Open, Classified
CACNone listed
Dec 2, 2023Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Open, Classified
KDQNone listed
Nov 16, 2023Atrium 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
CACNone listed
Nov 16, 2023Atrium Medical Corporation
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Open, Classified
CACNone listed
Dec 23, 2016Atrium 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
CACNone listed
Dec 23, 2016Atrium 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
CACNone listed
Dec 23, 2016Atrium 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
CACNone listed
Jun 29, 2015Atrium Medical Corporation
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Terminated
PADNone listed
Jun 29, 2015Atrium Medical Corporation
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
Terminated
PADNone listed
Jun 29, 2015Atrium Medical Corporation
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
Terminated
PADNone listed
Jun 29, 2015Atrium Medical Corporation
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Terminated
PADNone listed
Jul 1, 2014Atrium Medical Corporation
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Terminated
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Jan 14, 2014Atrium 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
CACNone listed
Feb 15, 2007Atrium Medical Corporation
Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
Terminated
CACNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.