DWC · Controller, Temperature, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4250 · Class 2
Overview
| Product Code | DWC |
|---|---|
| Device Name | Controller, Temperature, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220635 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | Nov 16, 2022 | SESE |
| K212657 | Quantum Heater-Cooler | Spectrum Medical , Ltd. | May 6, 2022 | SESE |
| K191402 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | Feb 25, 2020 | SESE |
| K140012 | SORIN FLEXTHERM | Sorin Group Deutschland GmbH | Jan 31, 2014 | SESE |
| K130300 | HEATER-COOLER UNIT HCU 40 | Maquet Cardiopulmonary, AG | Jul 1, 2013 | SESE |
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | Cincinnati Sub-Zero Products, Inc. | Dec 18, 2012 | SESE |
| K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 | Cardioquip Llp | Nov 19, 2010 | SESE |
| K071521 | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM | Terumo Cardiovascular Systems Corp. | Nov 21, 2007 | SESE |
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T | Sorin Group Deutschland GmbH | Jun 6, 2006 | SESE |
| K031544 | HEATER COOLER UNIT, MODEL HCU 30 | Jostra AB | Aug 7, 2003 | SESE |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | Minntech Corp. | Feb 1, 2002 | SESE |
| K003145 | ORIGEN BLADDER HOLDER | Origen Biomedical, Inc. | Apr 20, 2001 | SESE |
| K001520 | ALPHA OMEGA DUAL COOLER-HEATER | Alpha Omega, Inc. | Nov 22, 2000 | SESE |
| K945720 | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE | Jostra Bentley | Mar 29, 1995 | SESE |
| K896975 | CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE |
| K896974 | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE |
| K896973 | CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE |
| K896972 | CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE |
| K896971 | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE |
| K896393 | CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 | Daily Medical, Inc. | Feb 2, 1990 | SESE |
Top Applicants
- Daily Medical Products, Inc. — 5 clearances
- 3M Health Care, Sarns — 2 clearances
- Gambro, Inc. — 2 clearances
- Livanova Deutschland, GmbH — 2 clearances
- Sorin Group Deutschland GmbH — 2 clearances
