(b)(4).Catalog # igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.Summary of investigational findings: an investigation of the returned device found the filter still attached to the grasping hook and the introducer system still locked.However, after unlocking the system worked as intended and the filter could be advanced into and through the introducer sheath with no difficulties.Consequently, the exact reason for the difficulties encountered cannot be determined.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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