Cardiac Control Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 28
What Cardiac Control Systems, Inc. makes
Cardiac Control Systems, Inc. manufactures implantable cardiac pacemakers, including single-chamber and dual-chamber models such as the Maestro Series 100/200 and Maestro II Series 200. Their portfolio also includes temporary pacing catheters, such as the AV-shaped INT-AV610, and implantable pacing leads with tined fixation tips, like the Polysafe line. These devices are designed for bradycardia management and temporary cardiac support.
The company’s devices are regulated under FDA pathways, with pacemakers classified as Class II and Class III, and temporary pacing catheters as Class I. Authorisation records include 510(k) clearances and Premarket Approvals (PMA). The manufacturer is based in the United States.
Catalogue
Search and filter all 28 devicesFrequently asked questions
How many devices does Cardiac Control Systems, Inc. have in the registry?
The registry currently lists 28 devices for Cardiac Control Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Control Systems, Inc.'s devices?
Among its 28 most recently registered devices, Cardiac Control Systems, Inc. has devices listed in FDA 510(k) (26 devices) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cardiac Control Systems, Inc.'s devices fall under?
Among its 28 most recently registered devices, the classes recorded for Cardiac Control Systems, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Cardiac Control Systems, Inc. in the registry?
The most recently registered devices listed for Cardiac Control Systems, Inc. include CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK., MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER, CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER and CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA.