FDA-Device2017-04-26Class II

Cordis S.M.A.R.T. Flex Vascular Stent System

Cordis Corporation
Hazard

Deployment Difficulty.

Sold states
FOREIGN ONLY: ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, IRAN, ISRAEL, ITALY, JORDAN, KOREA (South), KUWAIT, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, POLAND, PORTUGAL, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED KINGDOM
Affected count
2,700
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis S.M.A.R.T. Flex Vascular Stent System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1826-2017

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