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 3M Health Care, Sarns, Sorin Group Deutschland GmbH and Livanova Deutschland, GmbH.

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 Jan 31, 2014
SORIN FLEXTHERM
K140012
Sorin Group Deutschland GmbH
Cardiovascular · 29d
Cleared Jul 01, 2013
HEATER-COOLER UNIT HCU 40
K130300
Maquet Cardiopulmonary, AG
Cardiovascular · 144d
Cleared Dec 18, 2012
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
K122813
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 96d
Cleared Nov 19, 2010
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
K102147
Cardioquip Llp
Cardiovascular · 112d
Cleared Nov 21, 2007
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
K071521
Terumo Cardiovascular Systems Corp.
Cardiovascular · 170d
Cleared Jun 06, 2006
STOCKERT HEATER-COOLER SYSTEM 3T
K052601
Sorin Group Deutschland GmbH
Cardiovascular · 258d
Cleared Feb 01, 2002
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016
Minntech Corp.
Cardiovascular · 58d
Cleared Apr 20, 2001
ORIGEN BLADDER HOLDER
K003145
Origen Biomedical, Inc.
Cardiovascular · 192d
Cleared Nov 22, 2000
ALPHA OMEGA DUAL COOLER-HEATER
K001520
Alpha Omega, Inc.
Cardiovascular · 190d
Cleared Nov 03, 1988
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
K883603
3M Health Care, Sarns
Cardiovascular · 72d
Cleared Feb 02, 1988
PTI HEART-CHILL POUCH/PAD SLING (STERILE)
K873924
Buckman Co., Inc.
Cardiovascular · 130d
Cleared Jan 29, 1988
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
K874927
Pioneering Technologies, Inc.
Cardiovascular · 58d
Cleared Nov 06, 1987
SARNS WARMER, PART #164975 AND #164980
K873813
3M Health Care, Sarns
Cardiovascular · 49d
Cleared Jul 18, 1983
HYPER-HYPOTHERMIA UNIT HYPO 10-200
K831677
Gambro, Inc.
Cardiovascular · 56d
Cleared Oct 18, 1982
THERMOSTATIC WATER MIXING VALVE TWV10
K822874
Gambro, Inc.
Cardiovascular · 21d
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.