MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
There is potential for nonsterility of product due to a possible defect in the pouch seal.
US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2441-2021