Criteria Industria E Comercio DE Produtos Medicinais
BrazilFDA applicant, unverified
- Devices
- 1
What Criteria Industria E Comercio DE Produtos Medicinais makes
Criteria Industria E Comercio DE Produtos Medicinais manufactures the Lumina-PTFE Titanium, a device featuring a titanium structure with expanded polytetrafluoroethylene (PTFE) coating. This product is designed for vascular applications, likely as a stent or graft, intended to support or replace damaged blood vessels.
The Lumina-PTFE Titanium is classified as a Class II medical device under FDA regulations and is supported by a 510(k) premarket notification submission. The company is based in the United States.
Catalogue
Lumina-PTFE Titanium Ref K221851
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Criteria Industria E Comercio DE Produtos Medicinais have in the registry?
The registry currently lists 1 device for Criteria Industria E Comercio DE Produtos Medicinais. Devices recorded under merged duplicate company entries are counted once.
Which registries list Criteria Industria E Comercio DE Produtos Medicinais's devices?
Among its 1 most recently registered device, Criteria Industria E Comercio DE Produtos Medicinais has devices listed in FDA 510(k) (1 device).
What risk classes do Criteria Industria E Comercio DE Produtos Medicinais's devices fall under?
Among its 1 most recently registered device, the classes recorded for Criteria Industria E Comercio DE Produtos Medicinais's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Criteria Industria E Comercio DE Produtos Medicinais in the registry?
The most recently registered devices listed for Criteria Industria E Comercio DE Produtos Medicinais include Lumina-PTFE Titanium.