DWE · Class II · 21 CFR 870.4390

FDA Product Code DWE: Tubing, Pump, Cardiopulmonary Bypass

Leading manufacturers include Maquet Cardiopulmonary, AG, 3M Health Care, Sarns and Terumo Cardiovascular Systems Corp..

21
Total
21
Cleared
102d
Avg days
1980
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Tubing, Pump, Cardiopulmonary Bypass Devices (Product Code DWE)

21 devices
1–21 of 21
Cleared Aug 08, 2024
SMARxT Tubing and Connectors
K233702
LivaNova USA, Inc.
Cardiovascular · 265d
Cleared Sep 11, 2008
HLM TUBING SET WITH BIOLINE COATING
K080592
Maquet Cardiopulmonary, AG
Cardiovascular · 192d
Cleared Nov 10, 2005
JOSTRA HLM TUBING SET
K053025
Maquet Cardiopulmonary, AG
Cardiovascular · 14d
Cleared Jan 22, 2002
PUMP TUBING
K013578
Terumo Cardiovascular Systems Corp.
Cardiovascular · 85d
Cleared Oct 26, 1998
COBE SMARXT TUBING AND CONNECTORS
K981613
Cobe Cardiovascular, Inc.
Cardiovascular · 173d
Cleared Feb 25, 1991
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686
3M Health Care, Sarns
Cardiovascular · 68d
Cleared Aug 10, 1984
SARNS EVACUPLEGE CATHETER
K842044
3M Health Care, Sarns
Cardiovascular · 81d
Cleared Apr 17, 1981
MEDRAD HIGH PRESSURE CONECTING TUBE
K810924
Medrad, Inc.
Cardiovascular · 11d
Cleared Jan 13, 1981
TYGON TUBING
K803277
Electromedics, Inc.
Cardiovascular · 15d
Cleared Feb 21, 1980
EXTRACORP.'S INTERSEPT CUS. TUBING PK.
K800178
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 24d

About Product Code DWE - Regulatory Context

510(k) Submission Activity

21 total 510(k) submissions under product code DWE since 1980, with 21 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.