Data / Medical devices / United States / CardioQuip
CardioQuip: FDA-registered device maker in College Station, TX, United States, 1 510(k) clearance
CardioQuip is registered with the FDA (registration 3007899424) in College Station, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2010. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007899424
- Address
- 8422 Calibration Ct, College Station, TX, United States, 77845
- Owner or operator
- CardioQuip LLC (10044068)
- Roles
- Manufacturer
- First device listed
- April 25, 2013
- Registered through
- 2027
- Brand names listed
- MCH Micro, MCH Mini, MCH-1000, MCH-1000(i), MCH-1000(m), MCH-1000(u), Modular Cooler-Heater, VC-1000 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer | accessdata.fda.gov |
| Controller, Temperature, Cardiopulmonary Bypass | DWC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2010 | K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 | DWC | Substantially Equivalent | Cardioquip Llp | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 24, 2023 | 93446 | Class II | Ongoing | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. | accessdata.fda.gov |
| October 19, 2023 | 93347 | Class II | Ongoing | CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. | accessdata.fda.gov |
| June 24, 2021 | 88621 | Class II | Ongoing | CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices. | There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection. | accessdata.fda.gov |
| May 12, 2021 | 88622 | Class II | Ongoing | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Controller, Temperature, Cardiopulmonary Bypass
Updated December 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.