Introstat
Country not established
- Devices
- 1
What Introstat makes
Introstat manufactures lead introducer sets, which are used for the insertion and positioning of cardiac leads during pacemaker or defibrillator implant procedures. These devices facilitate precise electrode placement within the heart chambers, supporting cardiac rhythm management therapies.
The company’s lead introducer sets are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The products are intended for use in the United States.
Catalogue
Lead Introducer Set Ref K790882
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Introstat have in the registry?
The registry currently lists 1 device for Introstat. Devices recorded under merged duplicate company entries are counted once.
Which registries list Introstat's devices?
Among its 1 most recently registered device, Introstat has devices listed in FDA 510(k) (1 device).
What risk classes do Introstat's devices fall under?
Among its 1 most recently registered device, the classes recorded for Introstat's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Introstat in the registry?
The most recently registered devices listed for Introstat include LEAD INTRODUCER SET.