Panels › Cardiovascular › Product code DWE · Class 2
Tubing, Pump, Cardiopulmonary Bypass
Regulation 870.4390
0510(k)s in 12 months (21 all time)
0recalls in 12 months (48 all time)
47recalls that name a 510(k)
Top companies in DWE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2024 | K233702 | SMARxT Tubing and Connectors LivaNova USA, Inc. | DWE |
| May 1, 2015 | K150542 | Terumo Pump Tubing Terumo Cardiovascular Systems Corporation | DWE |
| Dec 11, 2014 | K142607 | AngioVac Circuit Angiodynamics | DWE |
| Aug 28, 2009 | K092486 | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT Vortex Medical, Inc. | DWE |
| Sep 11, 2008 | K080592 | HLM TUBING SET WITH BIOLINE COATING Maquet Cardiopulmonary, AG, DE | DWE |
| Nov 10, 2005 | K053025 | JOSTRA HLM TUBING SET Maquet Cardiopulmonary, AG | DWE |
| Sep 19, 2002 | K022857 | PUMP TUBING WITH X-COATING Terumo Cardiovascular Systems Corporation | DWE |
| Jan 22, 2002 | K013578 | PUMP TUBING Terumo Cardiovascular Systems Corp. | DWE |
| Mar 1, 2000 | K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING Terumo Corp. | DWE |
| Dec 10, 1999 | K993062 | CHEST DRAINAGE TUBING Olson Medical Sales, Inc. | DWE |
| Oct 26, 1998 | K981613 | COBE SMARXT TUBING AND CONNECTORS Cobe Cardiovascular, Inc. | DWE |
| Jul 9, 1993 | K923231 | CARDIO-PAK BASIC PUMP PACK Cardio-Med-Associates, Inc. | DWE |
| Feb 25, 1991 | K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR 3M Health Care, Sarns | DWE |
| Dec 3, 1990 | K902845 | GENTLE HEADER Enhanced Perfusion Systems, Inc. | DWE |
| Oct 20, 1989 | K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE The Traumafuse Co. | DWE |
| Oct 19, 1984 | K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING Sterile Design, Inc. | DWE |
| Aug 10, 1984 | K842044 | SARNS EVACUPLEGE CATHETER 3M Health Care, Sarns | DWE |
| Apr 17, 1981 | K810924 | MEDRAD HIGH PRESSURE CONECTING TUBE Medrad, Inc. | DWE |
| Jan 13, 1981 | K803277 | TYGON TUBING Electromedics, Inc. | DWE |
| Jun 30, 1980 | K801394 | CARDIOPULMONARY BYPASS PUMP TUBING Texas Medical Products, Inc. | DWE |
| Feb 21, 1980 | K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc. | DWE |
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