Data / Medical devices / France / Nexstep Medical
Nexstep Medical: FDA-registered device maker in Dijon Cote-d'Or, France, 1 510(k) clearance
Nexstep Medical is registered with the FDA (registration 3016927279) in Dijon Cote-d'Or, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 15, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016927279
- Address
- 54G rue de la Prefecture, Dijon Cote-d'Or, France, 21000
- Owner or operator
- NexStep Medical (10074304)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 22, 2020
- Registered through
- 2026
- Brand names listed
- 035M All'InCath, All'InCath, All'InCath 035M, All'InCath CBC 035M, All'inCath, CBC 035M
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 15, 2020 | K191275 | AllInCath 035M PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Nexstep Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Continuous Flush
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
Updated January 15, 2020. 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.