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

FDA 510(k) Number Applicant Device Name Decision Date
K842044 3M HEALTH CARE, SARNS SARNS EVACUPLEGE CATHETER 08/10/1984
K905686 3M HEALTH CARE, SARNS SARNS TEMPERATURE PROBE AND CONNECTOR 02/25/1991
K142607 ANGIODYNAMICS AngioVac Circuit 12/11/2014
K923231 CARDIO-MED-ASSOCIATES, INC. CARDIO-PAK BASIC PUMP PACK 07/09/1993
K981613 COBE CARDIOVASCULAR, INC. COBE SMARXT TUBING AND CONNECTORS 10/26/1998
K933235 CORDIS CORP. CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF 01/06/1994
K803277 ELECTROMEDICS, INC. TYGON TUBING 01/13/1981
K902845 ENHANCED PERFUSION SYSTEMS, INC. GENTLE HEADER 12/03/1990
K800178 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. EXTRACORP.'S INTERSEPT CUS. TUBING PK. 02/21/1980
K080592 MAQUET CARDIOPULMONARY AG HLM TUBING SET WITH BIOLINE COATING 09/11/2008
K053025 MAQUET CARDIOPULMONARY AG JOSTRA HLM TUBING SET 11/10/2005
K810924 MEDRAD, INC. MEDRAD HIGH PRESSURE CONECTING TUBE 04/17/1981
K993062 OLSON MEDICAL SALES, INC. CHEST DRAINAGE TUBING 12/10/1999
K841959 STERILE DESIGN, INC. CARDIO METRIC CUSTOM PERFUSION TUBING 10/19/1984
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
K801394 TEXAS MEDICAL PRODUCTS, INC. CARDIOPULMONARY BYPASS PUMP TUBING 06/30/1980
K894721 THE TRAUMAFUSE CO. TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE 10/20/1989
K092486 VORTEX MEDICAL INC VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT 08/28/2009


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