Dectro Intl., Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Dectro Intl., Inc. makes
Dectro Intl., Inc. manufactures the APILUS ELECTROPIL, an electrophysiological device designed for cardiac mapping and ablation procedures. This tool supports precise localization and treatment of arrhythmias by delivering controlled electrical stimulation.
The APILUS ELECTROPIL is classified as a Class I medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Apilus Electropil Ref K943928
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dectro Intl., Inc. have in the registry?
The registry currently lists 1 device for Dectro Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dectro Intl., Inc.'s devices?
Among its 1 most recently registered device, Dectro Intl., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Dectro Intl., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dectro Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dectro Intl., Inc. in the registry?
The most recently registered devices listed for Dectro Intl., Inc. include APILUS ELECTROPIL.