CLINICAL TRIALS
FDA 510(k) CLEARANCES
--- Maxiocel Chitosan Wound Dressing by Advamedica Inc.
FDA cleared August 2023
Indication for use: The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration.
--- 091 Balloon Guide Catheter by EOSolutions, Corp.
FDA cleared October 2023
Indication for use: The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.