Cardeon Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What Cardeon Corp. makes
Cardeon Corp. manufactures vascular catheters and balloon cannulas, including the Cobra Catheter, Ascending Balloon Cannula (ABC), and modifications to the Aegis Catheter. These devices are designed for interventional procedures, such as guiding and dilating blood vessels during cardiac or peripheral interventions.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards.
Catalogue
Modification To Cardeon Aegis Catheter Ref K022174
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Modification To Cardeon Aegis Catheter Ref K024058
Regimes: 510(k) Registry: 510(k)Cardeon Cobra Catheter Ref K042156
Regimes: 510(k) Registry: 510(k)Cardeon Ascending Balloon Cannula (Abc) Ref K001371
Regimes: 510(k) Registry: 510(k)Cardeon Aegis Catheter Ref K013593
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardeon Corp. have in the registry?
The registry currently lists 6 devices for Cardeon Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardeon Corp.'s devices?
Among its 6 most recently registered devices, Cardeon Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Cardeon Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Cardeon Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardeon Corp. in the registry?
The most recently registered devices listed for Cardeon Corp. include MODIFICATION TO CARDEON AEGIS CATHETER, MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC), CARDEON COBRA CATHETER and CARDEON ASCENDING BALLOON CANNULA (ABC).