FDA 510(k) Applications for Medical Device Product Code "DWE"
(Tubing, Pump, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K142607 ANGIODYNAMICS AngioVac Circuit 12/11/2014
K981613 COBE CARDIOVASCULAR, INC. COBE SMARXT TUBING AND CONNECTORS 10/26/1998
K080592 MAQUET CARDIOPULMONARY AG HLM TUBING SET WITH BIOLINE COATING 09/11/2008
K053025 MAQUET CARDIOPULMONARY AG JOSTRA HLM TUBING SET 11/10/2005
K993062 OLSON MEDICAL SALES, INC. CHEST DRAINAGE TUBING 12/10/1999
K013578 TERUMO CARDIOVASCULAR SYSTEMS CORP. PUMP TUBING 01/22/2002
K022857 Terumo Cardiovascular Systems Corporation PUMP TUBING WITH X-COATING 09/19/2002
K150542 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION Terumo Pump Tubing 05/01/2015
K993189 TERUMO CORP. CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING 03/01/2000
K092486 VORTEX MEDICAL INC VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT 08/28/2009


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