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DWE — Tubing, Pump, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
DWE
Device Class
Class II
Regulation Number
870.4390
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233702livanova usaSMARxT Tubing and ConnectorsAugust 8, 2024
K150542terumo cardiovascular systems corporationTerumo Pump TubingMay 1, 2015
K142607angiodynamicsAngioVac CircuitDecember 11, 2014
K092486vortex medicalVORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUITAugust 28, 2009
K080592maquet cardiopulmonaryHLM TUBING SET WITH BIOLINE COATINGSeptember 11, 2008
K053025maquet cardiopulmonaryJOSTRA HLM TUBING SETNovember 10, 2005
K022857terumo cardiovascular systems corporationPUMP TUBING WITH X-COATINGSeptember 19, 2002
K013578terumo cardiovascular systemsPUMP TUBINGJanuary 22, 2002
K993189terumoCARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMMarch 1, 2000
K993062olson medical salesCHEST DRAINAGE TUBINGDecember 10, 1999
K981613cobe cardiovascularCOBE SMARXT TUBING AND CONNECTORSOctober 26, 1998
K923231cardio-med-associatesCARDIO-PAK BASIC PUMP PACKJuly 9, 1993
K9056863m health care, sarnsSARNS TEMPERATURE PROBE AND CONNECTORFebruary 25, 1991
K902845enhanced perfusion systemsGENTLE HEADERDecember 3, 1990
K894721traumafuseTRAUMAFUSE PERFUSION PRESSURE RELIEF VALVEOctober 20, 1989
K841959sterile designCARDIO METRIC CUSTOM PERFUSION TUBINGOctober 19, 1984
K8420443m health care, sarnsSARNS EVACUPLEGE CATHETERAugust 10, 1984
K810924medradMEDRAD HIGH PRESSURE CONECTING TUBEApril 17, 1981
K803277electromedicsTYGON TUBINGJanuary 13, 1981
K801394texas medical productsCARDIOPULMONARY BYPASS PUMP TUBINGJune 30, 1980