FDA-Device2015-07-01Class II
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Terumo Cardiovascular Systems Corp
Hazard
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Sold states
Distributed to the states of MO and FL.
Affected count
163 devices
Manufactured in
28 Howe St, Ashland, MA, United States
Products
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1828-2015Don't want to check this manually?
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