www.fdanews.com/articles/202907-prytime-gets-ce-mark-and-uk-clearance-for-next-generation-catheter

Prytime Gets CE Mark and UK Clearance for Next-Generation Catheter
May 26, 2021
Prytime Medical Devices received both CE mark certification and UK approval for its ER-REBOA PLUS catheter.
The device has now been cleared in the UK and EU for controlling noncompressible truncal hemorrhages. It features a leave-behind guidewire capability up to 0.025 inches for use in endovascular procedures.
The Plus catheter previously received clearance from the FDA and Health Canada.