FDA-Device2019-04-24Class III
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Cordis Corporation
Hazard
Frayed pieces of the mounting card being inside the primary packaging.
Sold states
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada
Affected count
23481
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1198-2019Don't want to check this manually?
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