Pacesetter Systems
Country not established
- Devices
- 98
What Pacesetter Systems makes
The company manufactures vascular prostheses, including the VASCUTEK VP1200K/50K for blood vessel replacement, and cardiovascular pacing devices such as permanent pacemaker electrodes, unipolar/bipolar pacing leads, and implantable endocardial pacemakers like the FASTPASS and FIRM LEAD. It also produces connector adapters for pacemakers, a personal medication infuser, and specialized pacing components such as the PACEMAKER CONNECTOR PLUG and PERMANTHANE bipolar coaxial lead.
The portfolio includes devices regulated under FDA Class I, II, and III classifications, with authorisation records in the 510(k) and PMA pathways. These products are listed in the US under FDA regulatory frameworks, and the company is based in the United States.
Catalogue
Search and filter all 98 devicesShowing 1-50 of 98
Frequently asked questions
How many devices does Pacesetter Systems have in the registry?
The registry currently lists 98 devices for Pacesetter Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pacesetter Systems's devices?
Among its 50 most recently registered devices, Pacesetter Systems has devices listed in FDA 510(k) (50 devices).
What risk classes do Pacesetter Systems's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Pacesetter Systems'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 Pacesetter Systems in the registry?
The most recently registered devices listed for Pacesetter Systems include VASCUTEK VASCULAR PROTHESIS VP1200K/50K, VIVALITH 5, - MDL-201A & TDL-201A, CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE and PACEMAKER CONNECTOR PLUG.