Product code DWC— Cardiovascular
Heater-Cooler System 3T
- Advisory panel
- Cardiovascular
- Total cleared
- 30
Adverse events under product code DWC
product code DWC- Death
- 124
- Injury
- 233
- Malfunction
- 3,727
- Total
- 4,084
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DWC
- K220635 — Heater-Cooler System 3T
- K212657 — Quantum Heater-Cooler
- K191402 — Heater-Cooler System 3T
- K140012 — SORIN FLEXTHERM
- K130300 — HEATER-COOLER UNIT HCU 40
- K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
- K102147 — CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
- K071521 — TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
- K052601 — STOCKERT HEATER-COOLER SYSTEM 3T
- K031544 — HEATER COOLER UNIT, MODEL HCU 30
- K014016 — ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
- K003145 — ORIGEN BLADDER HOLDER
- K001520 — ALPHA OMEGA DUAL COOLER-HEATER
- K945720 — JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
- K896971 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
- K896972 — CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
- K896973 — CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
- K896974 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
- K896975 — CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
- K896393 — CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
- K893940 — POLYSTAN HEATER-COOLER UNIT
- K883603 — SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
- K873924 — PTI HEART-CHILL POUCH/PAD SLING (STERILE)
- K874927 — PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
- K873699 — ECMO-TEMP (TM) BLOOD WARMING DEVICE
- K873813 — SARNS WARMER, PART #164975 AND #164980
- K841402 — TEMPERATURE CONTROL & MONITOR
- K831677 — HYPER-HYPOTHERMIA UNIT HYPO 10-200
- K822874 — THERMOSTATIC WATER MIXING VALVE TWV10
- K810647 — SHILEY OXYGENATOR THERMISTOR PROBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.