Karen Holtz
Country not established
- Devices
- 1
What Karen Holtz makes
Karen Holtz manufactures the INSULCAP, a device designed for the electrical insulation of medical leads, ensuring patient safety during cardiac procedures by preventing electrical conduction through the lead insulation.
The INSULCAP is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The manufacturer operates from the United States.
Catalogue
Insulcap Ref K952044
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Karen Holtz have in the registry?
The registry currently lists 1 device for Karen Holtz. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karen Holtz's devices?
Among its 1 most recently registered device, Karen Holtz has devices listed in FDA 510(k) (1 device).
What risk classes do Karen Holtz's devices fall under?
Among its 1 most recently registered device, the classes recorded for Karen Holtz's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Karen Holtz in the registry?
The most recently registered devices listed for Karen Holtz include INSULCAP.