Enpath Medical Incorporated
United StatesFDA applicant, unverified
- Devices
- 2
What Enpath Medical Incorporated makes
Enpath Medical Incorporated manufactures vascular access devices, including the Enpath Deflectable Catheter and the Enpath Safety Introducer, designed for use in medical procedures requiring precise catheter placement and safety features.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Enpath Deflectable Catheter Ref K043489
Regimes: 510(k) Registry: 510(k)Enpath Safety Introducer Ref K041708
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enpath Medical Incorporated have in the registry?
The registry currently lists 2 devices for Enpath Medical Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enpath Medical Incorporated's devices?
Among its 2 most recently registered devices, Enpath Medical Incorporated has devices listed in FDA 510(k) (2 devices).
What risk classes do Enpath Medical Incorporated's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Enpath Medical Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Enpath Medical Incorporated in the registry?
The most recently registered devices listed for Enpath Medical Incorporated include ENPATH DEFLECTABLE CATHETER and ENPATH SAFETY INTRODUCER.