HEATER COOLER UNIT, MODEL HCU 30— 510(k) K031544
Substantially EquivalentJostra AB
FDA 510(k) clearance K031544 for HEATER COOLER UNIT, MODEL HCU 30, Substantially Equivalent on 2003-08-07. Applicant: Jostra AB. Device class: 2.
Clearance details
- Applicant
- Jostra AB
- Product code
- Code DWC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- The Woodlands, TX, US
Recent devices under product code DWC
view allAdverse 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 →
Recalls naming K031544
K-number listed on FDA's recall record- Z-2140-2021 — Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
- Z-0348-2017 — Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
- Z-0589-2016 — Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031544.
Data sourced from openFDA. This site is unofficial and independent of the FDA.