DWE · Tubing, Pump, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4390 · Class 2
Overview
| Product Code | DWE |
|---|---|
| Device Name | Tubing, Pump, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4390 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | Aug 8, 2024 | SESE |
| K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | May 1, 2015 | SESE |
| K142607 | AngioVac Circuit | Angiodynamics | Dec 11, 2014 | SESE |
| K092486 | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | Vortex Medical, Inc. | Aug 28, 2009 | SESE |
| K080592 | HLM TUBING SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | Sep 11, 2008 | SESE |
| K053025 | JOSTRA HLM TUBING SET | Maquet Cardiopulmonary, AG | Nov 10, 2005 | SESE |
| K022857 | PUMP TUBING WITH X-COATING | Terumo Cardiovascular Systems Corporation | Sep 19, 2002 | SESE |
| K013578 | PUMP TUBING | Terumo Cardiovascular Systems Corp. | Jan 22, 2002 | SESE |
| K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | Terumo Corp. | Mar 1, 2000 | SESE |
| K993062 | CHEST DRAINAGE TUBING | Olson Medical Sales, Inc. | Dec 10, 1999 | SESE |
| K981613 | COBE SMARXT TUBING AND CONNECTORS | Cobe Cardiovascular, Inc. | Oct 26, 1998 | SESE |
| K923231 | CARDIO-PAK BASIC PUMP PACK | Cardio-Med-Associates, Inc. | Jul 9, 1993 | SESK |
| K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR | 3M Health Care, Sarns | Feb 25, 1991 | SESE |
| K902845 | GENTLE HEADER | Enhanced Perfusion Systems, Inc. | Dec 3, 1990 | SESE |
| K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | The Traumafuse Co. | Oct 20, 1989 | SESE |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Sterile Design, Inc. | Oct 19, 1984 | SESE |
| K842044 | SARNS EVACUPLEGE CATHETER | 3M Health Care, Sarns | Aug 10, 1984 | SESE |
| K810924 | MEDRAD HIGH PRESSURE CONECTING TUBE | Medrad, Inc. | Apr 17, 1981 | SESE |
| K803277 | TYGON TUBING | Electromedics, Inc. | Jan 13, 1981 | SESE |
| K801394 | CARDIOPULMONARY BYPASS PUMP TUBING | Texas Medical Products, Inc. | Jun 30, 1980 | SESE |
Top Applicants
- Terumo Cardiovascular Systems Corporation — 2 clearances
- Maquet Cardiopulmonary, AG — 2 clearances
- 3M Health Care, Sarns — 2 clearances
- Vortex Medical, Inc. — 1 clearance
- The Traumafuse Co. — 1 clearance
