FDA-Device2020-10-14Class II
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Hazard
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Sold states
U.S.: AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA and WV. O.U.S; Canada
Affected count
N/A
Manufactured in
22010 SE 51st St, N/A, Issaquah, WA, United States
Products
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2021Don't want to check this manually?
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