FDA-Device2022-04-13Class III
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
Cook Medical Incorporated
Hazard
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Sold states
US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
Affected count
24,641 units
Manufactured in
400 N Daniels Way, Bloomington, IN, United States
Products
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2022Don't want to check this manually?
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