Cardio-Pace Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Cardio-Pace Medical, Inc. makes
Cardio-Pace Medical, Inc. manufactures implantable cardiac pacemakers, including multi-programmable pacing systems and pulse generators. Their portfolio includes unipolar and bipolar pacing leads, such as the PINNACLE SR 8701 and 8702, as well as coated pulse generators like the DURAPULSE P101.
These devices are classified as Class III under FDA regulations and are supported by 510(k) clearances. The company operates within the United States.
Catalogue
Pinnacle Multi-Programmable Pacing Sys Ref K853771
Regimes: 510(k) Registry: 510(k)Pinnacle Sr 8701 - Unipolar & 8702 - Bipolar Ref K870142
Regimes: 510(k) Registry: 510(k)Cario-Pace Durapulse P101 Coated Pulse Generator Ref K853425
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio-Pace Medical, Inc. have in the registry?
The registry currently lists 3 devices for Cardio-Pace Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio-Pace Medical, Inc.'s devices?
Among its 3 most recently registered devices, Cardio-Pace Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Cardio-Pace Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cardio-Pace Medical, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Cardio-Pace Medical, Inc. in the registry?
The most recently registered devices listed for Cardio-Pace Medical, Inc. include PINNACLE MULTI-PROGRAMMABLE PACING SYS, PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR and CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR.