Data / Medical devices / Single Lumen Ecmo Cannula
Single Lumen Ecmo Cannula (QHW): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Single Lumen Ecmo Cannula (product code QHW, Class 2, 21 CFR 870.4100). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on January 15, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QHW
- Device class
- 2
- Regulation
- 870.4100
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Mexico | 1 |
Makers of Single Lumen Ecmo Cannula
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Specification developer | 2 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 2 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| MC3, Inc. | Dexter, MI, United States | Manufacturer | 1 | January 15, 2026 | 0 | 0 | 0 | api.fda.gov |
Updated January 15, 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.