FDA Product Code
FDA Product Code DWE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4390
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | 2024-08-08 | Traditional | PDF ↗ |
| K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | 2015-05-01 | Special | PDF ↗ |
| K142607 | AngioVac Circuit | Angiodynamics | 2014-12-11 | Traditional | PDF ↗ |
| K092486 | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | Vortex Medical, Inc. | 2009-08-28 | Traditional | PDF ↗ |
| K080592 | HLM TUBING SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008-09-11 | Special | PDF ↗ |
| K053025 | JOSTRA HLM TUBING SET | Maquet Cardiopulmonary, AG | 2005-11-10 | Traditional | PDF ↗ |
| K022857 | PUMP TUBING WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-09-19 | Special | PDF ↗ |
| K013578 | PUMP TUBING | Terumo Cardiovascular Systems Corp. | 2002-01-22 | Traditional | PDF ↗ |
| K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | Terumo Corp. | 2000-03-01 | Traditional | PDF ↗ |
| K993062 | CHEST DRAINAGE TUBING | Olson Medical Sales, Inc. | 1999-12-10 | Traditional | PDF ↗ |
| K981613 | COBE SMARXT TUBING AND CONNECTORS | Cobe Cardiovascular, Inc. | 1998-10-26 | Traditional | PDF ↗ |
| K923231 | CARDIO-PAK BASIC PUMP PACK | Cardio-Med-Associates, Inc. | 1993-07-09 | Traditional | PDF ↗ |
| K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR | 3M Health Care, Sarns | 1991-02-25 | Traditional | PDF ↗ |
| K902845 | GENTLE HEADER | Enhanced Perfusion Systems, Inc. | 1990-12-03 | Traditional | PDF ↗ |
| K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | The Traumafuse Co. | 1989-10-20 | Traditional | PDF ↗ |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Sterile Design, Inc. | 1984-10-19 | Traditional | PDF ↗ |
| K842044 | SARNS EVACUPLEGE CATHETER | 3M Health Care, Sarns | 1984-08-10 | Traditional | PDF ↗ |
| K810924 | MEDRAD HIGH PRESSURE CONECTING TUBE | Medrad, Inc. | 1981-04-17 | Traditional | PDF ↗ |
| K803277 | TYGON TUBING | Electromedics, Inc. | 1981-01-13 | Traditional | PDF ↗ |
| K801394 | CARDIOPULMONARY BYPASS PUMP TUBING | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. | Extracorporeal Medical Specialities, Inc. | 1980-02-21 | Traditional | PDF ↗ |
Product code DWE · Class II · Cardiovascular. Data: openFDA.