Philips Medical System Nederland B.V.
NetherlandsFDA applicant, unverified
- Devices
- 1
What Philips Medical System Nederland B.V. makes
Philips Medical System Nederland B.V. manufactures electrophysiology (EP) mapping and ablation devices, including the AltaTrack equipment for cardiac mapping, the AltaTrack Guidewire for intracardiac navigation, and the AltaTrack Catheter for precise tissue ablation during heart rhythm procedures.
These products fall under Class II regulatory classification in the US and are listed via FDA 510(k) clearance. The company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Philips Medical System Nederland B.V. have in the registry?
The registry currently lists 1 device for Philips Medical System Nederland B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Philips Medical System Nederland B.V.'s devices?
Among its 1 most recently registered device, Philips Medical System Nederland B.V. has devices listed in FDA 510(k) (1 device).
What risk classes do Philips Medical System Nederland B.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Philips Medical System Nederland B.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Philips Medical System Nederland B.V. in the registry?
The most recently registered devices listed for Philips Medical System Nederland B.V. include AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter.