FDA-Device2014-06-18Class II
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Cordis Corporation
Hazard
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
Sold states
Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates.
Affected count
80 units
Manufactured in
14201 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1784-2014Don't want to check this manually?
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