FDA-Device2013-08-07Class II
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
HeartWare Inc
Hazard
Potential to electrostatic discharged (ESD)
Sold states
Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Affected count
76 (US) and 82 (International)
Manufactured in
14400 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2013Don't want to check this manually?
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