FDA-Device2021-12-08Class II
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Boston Scientific Corporation
Hazard
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Sold states
US Nationwide distribution.
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0325-2022Don't want to check this manually?
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