DWC · Class II · 21 CFR 870.4250

FDA Product Code DWC: Controller, Temperature, Cardiopulmonary Bypass

If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Leading manufacturers include Livanova Deutschland, GmbH, Spectrum Medical , Ltd. and Shiley, Inc..

30
Total
30
Cleared
114d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Controller, Temperature, Cardiopulmonary Bypass Devices (Product Code DWC)

30 devices
1–24 of 30
Cleared Nov 16, 2022
Heater-Cooler System 3T
K220635
Livanova Deutschland, GmbH
Cardiovascular · 257d
Cleared May 06, 2022
Quantum Heater-Cooler
K212657
Spectrum Medical , Ltd.
Cardiovascular · 256d
Cleared Feb 25, 2020
Heater-Cooler System 3T
K191402
Livanova Deutschland, GmbH
Cardiovascular · 277d
Cleared Apr 03, 1981
SHILEY OXYGENATOR THERMISTOR PROBE
K810647
Shiley, Inc.
Cardiovascular · 23d

About Product Code DWC - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code DWC since 1981, with 30 receiving FDA clearance (average review time: 114 days).

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