FDA 510(k) Applications Submitted by C2 THERAPEUTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K161202 04/28/2016 C2 Cryoballoon Ablation System C2 THERAPEUTICS, INC.
K160994 04/08/2016 C2 CryoBalloon Focal Pear Catheter C2 THERAPEUTICS, INC.
K151054 04/20/2015 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System C2 Therapeutics, Inc.
K152140 08/03/2015 Boa Endoscopic Valve C2 THERAPEUTICS, INC.
K152329 08/18/2015 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System C2 Therapeutics, Inc.
K153541 12/10/2015 Coldplay CryoBalloon« Ablation System C2 THERAPEUTICS, INC.
K163684 12/28/2016 C2 CryoBalloon Ablation System C2 Therapeutics, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact