FDA-Device2021-04-07Class II
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Oscor, Inc.
Hazard
Potential for open seal on sterile product
Sold states
US Nationwide distribution in the state of New York.
Affected count
500 devices
Manufactured in
3816 Desoto Blvd, Palm Harbor, FL, United States
Products
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2021Don't want to check this manually?
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