FDA-Device2018-10-10Class II
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Surge Medical Sales, LLC (DBA Surge Cardiovascular)
Hazard
The device was built with the rigid insertion stylet instead of the flexible stylet.
Sold states
US Distribution to state of: SC.
Affected count
35 units
Manufactured in
2680 Walker Ave Nw, Grand Rapids, MI, United States
Products
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2019Don't want to check this manually?
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