Company
CardioQuip, LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 9 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A Open, Classified |
DWC | K102147 |
| Dec 15, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A Open, Classified |
DWC | K102147 |
| Dec 1, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A Open, Classified |
DWC | K102147 |
| Dec 1, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A Open, Classified |
DWC | K102147 |
| 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 | K102147 |
| 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 | K102147 |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127 Open, Classified |
DWC | K102147 |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 Open, Classified |
DWC | K102147 |
| 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 | K102147 |