Ev3 Neurovascular
Country not established
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Ev3 Neurovascular makes
The company manufactures neurovascular devices, including occlusion balloon systems for embolization procedures, such as the Hyperglide and Hyperform models, and guidewires like the Meridian. It also produces microcatheters, such as the Apollo Onyx Delivery Micro Catheter, designed for delivering embolic agents in cerebral vascular treatments.
These devices are regulated under FDA pathways, with occlusion balloons and related embolization tools classified as Class II and Class III. Authorisation records include 510(k) clearances and Premarket Approvals (PMA). The company is based in the United States.
Catalogue
- 510(k) 510(k)
Meridian Guidewire Ref K093681
510(k) 510(k)- 510(k) 510(k)
Apollo Onyx Delivery Micro Catheter Ref P030004
PMA PMA
FDA recalls
FDA recall records list 1 recall initiated by Ev3 Neurovascular, initiated on 2007-04-05. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 5 Apr 2007 Z-0839-2007 Unclassified (pre-2012) Terminated Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.
Full distribution text
- 5 Apr 2007 Z-0839-2007 Unclassified (pre-2012) Terminated Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.
Frequently asked questions
How many devices does Ev3 Neurovascular have in the registry?
The registry currently lists 4 devices for Ev3 Neurovascular. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ev3 Neurovascular's devices?
Among its 4 most recently registered devices, Ev3 Neurovascular has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ev3 Neurovascular's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ev3 Neurovascular's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Ev3 Neurovascular?
FDA recall records list 1 recall initiated by Ev3 Neurovascular, the most recent initiated on 2007-04-05. 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 Ev3 Neurovascular in the registry?
The most recently registered devices listed for Ev3 Neurovascular include HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315, MERIDIAN GUIDEWIRE, HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127, 104-4132, 104 and Apollo Onyx Delivery Micro Catheter.