FDA-Device2021-09-15Class II
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Mivi Neuroscience Inc
Hazard
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Sold states
US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
Affected count
68 units
Manufactured in
6545 City West Pkwy, N/A, Eden Prairie, MN, United States
Products
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2021Don't want to check this manually?
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