Cordis Leads, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Cordis Leads, Inc. makes
Cordis Leads, Inc. manufactures temporary and permanent percutaneous leads for cardiac pacing and defibrillation, including high-torque leads with depth markers, unipolar and bipolar atrial leads, and specialized ventricular leads with fixed electrode configurations.
The company’s products are regulated under FDA Class II and Class III devices, with many authorised via the 510(k) pathway. These leads are listed in the FDA’s 510(k) database, reflecting their compliance with US medical device regulations.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Changes To Encor Pervenous J-Atrial Leads Ref K873772
Regimes: 510(k) Registry: 510(k)Encor Unipolar Vs-1 Leads Ref K883070
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cordis Leads, Inc. have in the registry?
The registry currently lists 4 devices for Cordis Leads, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cordis Leads, Inc.'s devices?
Among its 4 most recently registered devices, Cordis Leads, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Cordis Leads, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Cordis Leads, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Cordis Leads, Inc. in the registry?
The most recently registered devices listed for Cordis Leads, Inc. include HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK, CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS, ENCOR UNIPOLAR VS-1 LEADS and ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201.