Vygon Neuro
Country not established
- Devices
- 1
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Vygon Neuro makes
Vygon Neuro manufactures the NEUROCATH AG, a neurovascular catheter designed for interventional neuroradiology procedures, including cerebral angiography and embolization.
The NEUROCATH AG is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Neurocath AG Ref K081942
510(k) 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Vygon Neuro, initiated on 2005-03-24. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 24 Mar 2005 Z-0365-06 Unclassified (pre-2012) Terminated stylet in package is shorter than that claimed on the label
- 24 Mar 2005 Z-0366-06 Unclassified (pre-2012) Terminated stylet in package is shorter than that claimed on the label
- 24 Mar 2005 Z-0367-06 Unclassified (pre-2012) Terminated stylet in package is shorter than that claimed on the label
Frequently asked questions
How many devices does Vygon Neuro have in the registry?
The registry currently lists 1 device for Vygon Neuro. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vygon Neuro's devices?
Among its 1 most recently registered device, Vygon Neuro has devices listed in FDA 510(k) (1 device).
What risk classes do Vygon Neuro's devices fall under?
Among its 1 most recently registered device, the classes recorded for Vygon Neuro's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vygon Neuro?
FDA recall records list 3 recalls initiated by Vygon Neuro, the most recent initiated on 2005-03-24. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Vygon Neuro in the registry?
The most recently registered devices listed for Vygon Neuro include NEUROCATH AG.