Data / Medical devices / France / Hexacath
Hexacath: FDA-registered device maker in Rueil Malmaison Ile-de-France, France, 1 510(k) clearance
Hexacath is registered with the FDA (registration 3013134719) in Rueil Malmaison Ile-de-France, France. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013134719
- Address
- 2, rue Joseph Monier, Rueil Malmaison Ile-de-France, France, 92500
- Owner or operator
- HEXACATH (10088125)
- Roles
- Manufacturer
- First device listed
- May 30, 2023
- Registered through
- 2026
- Brand names listed
- RAYFLOW
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 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 |
|---|---|---|---|---|---|---|
| April 6, 2023 | K222023 | RayFlow | DQY | Substantially Equivalent | Hexacath | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Continuous Flush
- All makers of Catheter, Percutaneous
Updated April 6, 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.