DWC — Controller, Temperature, Cardiopulmonary Bypass Class II
FDA product code DWC covers "Controller, Temperature, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4250. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| 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 |
| K896971 | daily medical products | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 | 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 |