DWE — Tubing, Pump, Cardiopulmonary Bypass Class II
FDA product code DWE covers "Tubing, Pump, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4390. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DWE
- Device Class
- Class II
- Regulation Number
- 870.4390
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233702 | livanova usa | SMARxT Tubing and Connectors | August 8, 2024 |
| K150542 | terumo cardiovascular systems corporation | Terumo Pump Tubing | May 1, 2015 |
| K142607 | angiodynamics | AngioVac Circuit | December 11, 2014 |
| K092486 | vortex medical | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | August 28, 2009 |
| K080592 | maquet cardiopulmonary | HLM TUBING SET WITH BIOLINE COATING | September 11, 2008 |
| K053025 | maquet cardiopulmonary | JOSTRA HLM TUBING SET | November 10, 2005 |
| K022857 | terumo cardiovascular systems corporation | PUMP TUBING WITH X-COATING | September 19, 2002 |
| K013578 | terumo cardiovascular systems | PUMP TUBING | January 22, 2002 |
| K993189 | terumo | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUM | March 1, 2000 |
| K993062 | olson medical sales | CHEST DRAINAGE TUBING | December 10, 1999 |
| K981613 | cobe cardiovascular | COBE SMARXT TUBING AND CONNECTORS | October 26, 1998 |
| K923231 | cardio-med-associates | CARDIO-PAK BASIC PUMP PACK | July 9, 1993 |
| K905686 | 3m health care, sarns | SARNS TEMPERATURE PROBE AND CONNECTOR | February 25, 1991 |
| K902845 | enhanced perfusion systems | GENTLE HEADER | December 3, 1990 |
| K894721 | traumafuse | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | October 20, 1989 |
| K841959 | sterile design | CARDIO METRIC CUSTOM PERFUSION TUBING | October 19, 1984 |
| K842044 | 3m health care, sarns | SARNS EVACUPLEGE CATHETER | August 10, 1984 |
| K810924 | medrad | MEDRAD HIGH PRESSURE CONECTING TUBE | April 17, 1981 |
| K803277 | electromedics | TYGON TUBING | January 13, 1981 |
| K801394 | texas medical products | CARDIOPULMONARY BYPASS PUMP TUBING | June 30, 1980 |