Pci
Country not established
- Devices
- 2
What Pci makes
The company manufactures Class II percutaneous coronary intervention (PCI) devices, including the PCI 2500 and PCI 4000 systems. These products are designed for coronary angioplasty and stent delivery, facilitating the treatment of coronary artery disease through catheter-based interventions.
The portfolio is regulated under the FDA’s 510(k) clearance process and falls under Class II medical devices. The company’s devices are listed in the FDA’s 510(k) registry, adhering to U.S. regulatory requirements for percutaneous coronary intervention systems. The manufacturer operates from the United States.
Catalogue
Frequently asked questions
How many devices does Pci have in the registry?
The registry currently lists 2 devices for Pci. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pci's devices?
Among its 2 most recently registered devices, Pci has devices listed in FDA 510(k) (2 devices).
What risk classes do Pci's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pci's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pci in the registry?
The most recently registered devices listed for Pci include PCI 2500 and PCI 4000.