510(k) K102147 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
| Applicant | Cardioquip Llp, Bryan TX, US |
| Decision | Substantially Equivalent, Nov 19, 2010 |
| Received | Jul 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A Open, Classified |
DWC | None listed |
| Dec 15, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A Open, Classified |
DWC | None listed |
| Dec 1, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A Open, Classified |
DWC | None listed |
| Dec 1, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A Open, Classified |
DWC | None listed |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 Open, Classified |
DWC | None listed |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127 Open, Classified |
DWC | None listed |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110 Open, Classified |
DWC | None listed |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134 Open, Classified |
DWC | None listed |
| Jun 24, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices. Open, Classified |
DWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.