FDA-Device2022-04-13Class III
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
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
52,590 units
Manufactured in
400 N Daniels Way, Bloomington, IN, United States
Products
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0876-2022Don't want to check this manually?
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