Pristine Access Technologies, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Pristine Access Technologies, Ltd. makes
Pristine Access Technologies, Ltd. manufactures the Pristine Hemodialysis Catheter, a medical device designed for vascular access during hemodialysis procedures.
The company’s product portfolio is regulated as Class II devices under FDA 510(k) clearance requirements. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Pristine Hemodialysis Catheter Ref K182443
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pristine Access Technologies, Ltd. have in the registry?
The registry currently lists 1 device for Pristine Access Technologies, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pristine Access Technologies, Ltd.'s devices?
Among its 1 most recently registered device, Pristine Access Technologies, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Pristine Access Technologies, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Pristine Access Technologies, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pristine Access Technologies, Ltd. in the registry?
The most recently registered devices listed for Pristine Access Technologies, Ltd. include Pristine Hemodialysis Catheter.