510(k) K031544 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
HEATER COOLER UNIT, MODEL HCU 30
| Applicant | Jostra AB, The Woodlands TX, US |
| Decision | Substantially Equivalent, Aug 7, 2003 |
| Received | May 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2021 | Maquet Medical Systems USA 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 pa Terminated |
DWC | None listed |
| Sep 27, 2016 | Maquet Cardiovascular Us Sales, Llc 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 b Terminated |
DWC | None listed |
| Jan 5, 2016 | Maquet Cardiovascular Us Sales, Llc 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 coo Terminated |
DWC | None listed |
| Jan 25, 2007 | MAQUET Inc. Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine Terminated |
DWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.