DWC — Controller, Temperature, Cardiopulmonary Bypass Class II
Classification Details
- Product Code
- DWC
- Device Class
- Class II
- Regulation Number
- 870.4250
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220635 | livanova deutschland | Heater-Cooler System 3T | November 16, 2022 |
| K212657 | spectrum medical | Quantum Heater-Cooler | May 6, 2022 |
| K191402 | livanova deutschland | Heater-Cooler System 3T | February 25, 2020 |
| K140012 | sorin group deutschland | SORIN FLEXTHERM | January 31, 2014 |
| K130300 | maquet cardiopulmonary | HEATER-COOLER UNIT HCU 40 | July 1, 2013 |
| K122813 | cincinnati sub-zero products | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | December 18, 2012 |
| K102147 | cardioquip | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 | November 19, 2010 |
| K071521 | terumo cardiovascular systems | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM | November 21, 2007 |
| K052601 | sorin group deutschland | STOCKERT HEATER-COOLER SYSTEM 3T | June 6, 2006 |
| K031544 | jostra | HEATER COOLER UNIT, MODEL HCU 30 | August 7, 2003 |
| K014016 | minntech | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | February 1, 2002 |
| K003145 | origen biomedical | ORIGEN BLADDER HOLDER | April 20, 2001 |
| K001520 | alpha omega | ALPHA OMEGA DUAL COOLER-HEATER | November 22, 2000 |
| K945720 | jostra bentley | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEV | March 29, 1995 |
| K896971 | daily medical products | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 | February 5, 1990 |
| K896972 | daily medical products | CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 | February 5, 1990 |
| K896973 | daily medical products | CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 | February 5, 1990 |
| K896974 | daily medical products | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 | February 5, 1990 |
| K896975 | daily medical products | CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 | February 5, 1990 |
| K896393 | daily medical | CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 | February 2, 1990 |