FDA-Device2015-07-01Class II
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Volcano Corporation
Hazard
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Sold states
US Nationwide Distribution and one account in Canada.
Affected count
162 total (both devices)
Manufactured in
2870 Kilgore Rd, Rancho Cordova, CA, United States
Products
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2015Don't want to check this manually?
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