Data / Medical devices / Controller, Temperature, Cardiopulmonary Bypass
Controller, Temperature, Cardiopulmonary Bypass (DWC): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Controller, Temperature, Cardiopulmonary Bypass (product code DWC, Class 2, 21 CFR 870.4250). 6 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on November 16, 2022, and lists 29 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DWC
- Device class
- 2
- Regulation
- 870.4250
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 2 |
| United Kingdom | 1 |
Makers of Controller, Temperature, Cardiopulmonary Bypass
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| LivaNova Deutschland GmbH | MUNCHEN Bavaria, Germany | Specification developer | 2 | November 16, 2022 | 0 | 1 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Complaint file establishment, Manufacturer | 2 | November 3, 1988 | 0 | 7 | 0 | api.fda.gov |
| CardioQuip | College Station, TX, United States | Manufacturer | 1 | November 19, 2010 | 0 | 4 | 0 | api.fda.gov |
| Genesee Biomedical, Inc. | Denver, CO, United States | Contract manufacturer, Manufacturer, Specification developer | 1 | January 29, 1988 | 0 | 0 | 0 | api.fda.gov |
| Gentherm Medical, LLC | Cincinnati, OH, United States | Manufacturer, Manufacturer for export | 1 | December 18, 2012 | 0 | 5 | 0 | api.fda.gov |
| Spectrum Medical Ltd | GLOUCESTER Gloucestershire, United Kingdom | Manufacturer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Lauda DR. R. Wobser GMBH & Co. KG | Laudaplatz 1 Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quest Medical, Inc. | Allen, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 16, 2022. 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.