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C2 Therapeutics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1477-2017Class IIC2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, CryoJanuary 6, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K163684C2 CryoBalloon Ablation SystemJanuary 23, 2018
K161202C2 Cryoballoon Ablation SystemJanuary 5, 2017
K160994C2 CryoBalloon Focal Pear CatheterMay 19, 2016
K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemApril 13, 2016
K153541Coldplay CryoBalloon® Ablation SystemJanuary 7, 2016
K152140Boa Endoscopic ValveOctober 13, 2015
K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemJuly 7, 2015
K150083Sidecar External Working ChannelApril 14, 2015
K131523CRYOBALLOON FOCAL ABLATION SYSTEMAugust 22, 2013
K101825CRYOBALLOON ABLATION SYSTEMSeptember 29, 2010