SmartWise Sweden AB
SwedenFDA applicant, unverified
- Devices
- 2
What SmartWise Sweden AB makes
SmartWise Sweden AB manufactures the Extroducer Infusion Catheter System, a device designed for intravenous infusion and fluid administration in medical settings.
This product is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway in the United States.
Catalogue
Extroducer Infusion Catheter System Ref K254051
Regimes: 510(k) Registry: 510(k)Extroducer Infusion Catheter System Ref K213442
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does SmartWise Sweden AB have in the registry?
The registry currently lists 2 devices for SmartWise Sweden AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list SmartWise Sweden AB's devices?
Among its 2 most recently registered devices, SmartWise Sweden AB has devices listed in FDA 510(k) (2 devices).
What risk classes do SmartWise Sweden AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for SmartWise Sweden AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from SmartWise Sweden AB in the registry?
The most recently registered devices listed for SmartWise Sweden AB include Extroducer Infusion Catheter System.