Nexstep Medical
FranceFDA applicant, unverified FDA FEI 3016927279
- Devices
- 48
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Nexstep Medical makes
Nexstep Medical manufactures peripheral angioplasty balloon catheters designed for percutaneous transluminal angioplasty (PTA), a procedure to widen narrowed or obstructed blood vessels in the peripheral arteries. Their primary product, the All'InCath 035M PTA Balloon Dilatation Catheter, is intended for use in treating vascular conditions requiring mechanical dilation of arterial lesions.
The company’s devices are classified as Class II under the FDA regulatory framework and are authorised through the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
Catalogue
Search and filter all 48 devicesCompany details
- FDA FEI number
- 3016927279
- DUNS number
- 266039102
- Address
- 54G rue de la Prefecture, Dijon Cote-d'Or
- [email protected]
- Phone
- 9999999999
Frequently asked questions
How many devices does Nexstep Medical have in the registry?
The registry currently lists 48 devices for Nexstep Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nexstep Medical's devices?
Among its 48 most recently registered devices, Nexstep Medical has devices listed in FDA 510(k) (1 device) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nexstep Medical's devices fall under?
Among its 48 most recently registered devices, the classes recorded for Nexstep Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nexstep Medical in the registry?
The most recently registered devices listed for Nexstep Medical include All'InCath 035M PTA Balloon Dilatation Catheter 1 and All’InCath 035M PTA Balloon Dilatation Catheter.