Data / Medical devices / Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure (QJZ): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure (product code QJZ, Class 2, 21 CFR 870.4100). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 31, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QJZ
- Device class
- 2
- Regulation
- 870.4100
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| United States | 1 |
| Mexico | 1 |
Makers of Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
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 |
|---|---|---|---|---|---|---|---|---|
| MC3, Inc. | Dexter, MI, United States | Manufacturer, Manufacturer for export, Specification developer | 2 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 2 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Xenios AG | Stolberg North Rhine-Westphalia, Germany | Manufacturer | 2 | April 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Xenios AG | Reutlingen Baden-Wurttemberg, Germany | Specification developer | 2 | April 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Xenios AG | Heilbronn Baden-Wurttemberg, Germany | Specification developer | 2 | April 15, 2024 | 0 | 0 | 0 | api.fda.gov |
Updated July 31, 2026. 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.