FDA-Device2018-06-27Class II
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
PENTAX of America Inc
Hazard
The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
Sold states
Distribution US nationwide.
Affected count
57 units
Manufactured in
303 Convention Way Ste 1, N/A, Redwood City, CA, United States
Products
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2256-2018Don't want to check this manually?
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