Data / Medical devices / United States / Qxmedical, LLC
Qxmedical, LLC: FDA-registered device maker in Saint Paul, MN, United States, 3 510(k) clearances
Qxmedical, LLC is registered with the FDA (registration 3009766315) in Saint Paul, MN, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 24, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009766315
- Address
- 2820 Patton Rd, Saint Paul, MN, United States, 55113
- Owner or operator
- QXMedical, LLC (10041546)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- August 3, 2012
- Registered through
- 2027
- Brand names listed
- Aortic Balloon, Boosting Catheter, Q50 PLUS Stent Graft Balloon Catheter, Q50X Stent Graft Balloon Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Electrode, Cortical | GYC | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Depth | GZL | 2 | Contract manufacturer | accessdata.fda.gov |
| Generator, Lesion, Radiofrequency | GXD | 2 | Contract manufacturer | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| April 24, 2019 | K183679 | Occlusion Balloon Catheter | MJN | Substantially Equivalent | Qxmedical, LLC | accessdata.fda.gov |
| November 2, 2016 | K160561 | Boosting Catheter | DQY | Substantially Equivalent | Qxmedical, LLC | accessdata.fda.gov |
| February 24, 2012 | K120381 | Q50 PLUS STENT GRAFT BALLOON CATHETER | DQY | Substantially Equivalent | Qxmedical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Depth
- All makers of Catheter, Percutaneous
- All makers of Catheter, Intravascular Occluding, Temporary
- All makers of Probe, Radiofrequency Lesion
- All makers of Generator, Lesion, Radiofrequency
- All makers of Electrode, Cortical
Updated April 24, 2019. 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.