Product code DWE
- Device name
- Tubing, Pump, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4390
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | 2024-08-08 |
| K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | 2015-05-01 |
| K142607 | AngioVac Circuit | Angiodynamics | 2014-12-11 |
| K092486 | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | Vortex Medical, Inc. | 2009-08-28 |
| K080592 | HLM TUBING SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008-09-11 |
| K053025 | JOSTRA HLM TUBING SET | Maquet Cardiopulmonary, AG | 2005-11-10 |
| K022857 | PUMP TUBING WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-09-19 |
| K013578 | PUMP TUBING | Terumo Cardiovascular Systems Corp. | 2002-01-22 |
| K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | Terumo Corp. | 2000-03-01 |
| K993062 | CHEST DRAINAGE TUBING | Olson Medical Sales, Inc. | 1999-12-10 |
| K981613 | COBE SMARXT TUBING AND CONNECTORS | Cobe Cardiovascular, Inc. | 1998-10-26 |
| K923231 | CARDIO-PAK BASIC PUMP PACK | Cardio-Med-Associates, Inc. | 1993-07-09 |
| K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR | 3M Health Care, Sarns | 1991-02-25 |
| K902845 | GENTLE HEADER | Enhanced Perfusion Systems, Inc. | 1990-12-03 |
| K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | The Traumafuse Co. | 1989-10-20 |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Sterile Design, Inc. | 1984-10-19 |
| K842044 | SARNS EVACUPLEGE CATHETER | 3M Health Care, Sarns | 1984-08-10 |
| K810924 | MEDRAD HIGH PRESSURE CONECTING TUBE | Medrad, Inc. | 1981-04-17 |
| K803277 | TYGON TUBING | Electromedics, Inc. | 1981-01-13 |
| K801394 | CARDIOPULMONARY BYPASS PUMP TUBING | Texas Medical Products, Inc. | 1980-06-30 |
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. | Extracorporeal Medical Specialities, Inc. | 1980-02-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| H965252810 | AngioVac | NAVILYST MEDICAL, INC. | 2020-05-11 |
| 00613994352811 | Intersept® | MEDTRONIC, INC. | 2016-06-17 |
| 00613994363237 | Intersept® | MEDTRONIC, INC. | 2016-05-28 |
| 00613994363220 | Intersept® | MEDTRONIC, INC. | 2016-05-28 |
| 00613994097408 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994392060 | INTERSEPT® | MEDTRONIC, INC. | 2016-05-22 |
| 00613994390905 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994387530 | INTERSEPT® | MEDTRONIC, INC. | 2016-05-22 |
| 00613994360724 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994290632 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994290618 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994287908 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994268716 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994243355 | INTERSEPT® | MEDTRONIC, INC. | 2016-05-22 |
| 00613994117175 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994239099 | NA | MEDTRONIC, INC. | 2016-05-22 |
| 00613994400949 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994283443 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994128614 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994171436 | INTERSEPT® | MEDTRONIC, INC. | 2016-05-21 |
| 00613994379993 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994367549 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994176387 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994176400 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994217684 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994349644 | INTERSEPT® | MEDTRONIC, INC. | 2016-05-21 |
| 00613994341068 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994328717 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994310132 | NA | MEDTRONIC, INC. | 2016-05-21 |
| 00613994264381 | NA | MEDTRONIC, INC. | 2016-05-21 |