FDA-Device2013-04-24Class II
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Elana, Inc.
Hazard
Distribution of an unapproved device into interstate commerce.
Sold states
Distributed in the states of Pennsylvania, Texas, and New York.
Affected count
3 devices
Manufactured in
10480 Little Patuxent Pkwy, Suite 400, Columbia, MD, United States
Products
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1143-2013Don't want to check this manually?
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