FDA-Device2021-11-24Class II
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Cordis Corporation
Hazard
There is a potential for distal tip dislodgement or separation.
Sold states
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
Affected count
4 units
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0220-2022Don't want to check this manually?
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