Company · US
C2 Therapeutics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2018. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 23, 2018 | K163684 | C2 CryoBalloon Ablation System C2 Therapeutics, Inc. | GEH |
| Jan 5, 2017 | K161202 | C2 Cryoballoon Ablation System C2 Therapeutics, Inc. | GEH |
| May 19, 2016 | K160994 | C2 CryoBalloon Focal Pear Catheter C2 Therapeutics, Inc. | GEH |
| Apr 13, 2016 | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System C2 Therapeutics, Inc. | GEH |
| Jan 7, 2016 | K153541 | Coldplay CryoBalloon® Ablation System C2 Therapeutics, Inc. | GEH |
| Oct 13, 2015 | K152140 | Boa Endoscopic Valve C2 Therapeutics, Inc. | OCX |
| Jul 7, 2015 | K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System C2 Therapeutics, Inc. | GEH |
| Apr 14, 2015 | K150083 | Sidecar External Working Channel C2 Therapeutics | FED |
| Aug 22, 2013 | K131523 | CRYOBALLOON FOCAL ABLATION SYSTEM C2 Therapeutics | GEH |
| Sep 29, 2010 | K101825 | CRYOBALLOON ABLATION SYSTEM C2 Therapeutics | GEH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2017 | C2 Therapeutics, Inc. C2 CryoBalloon Ablation System - Controller Cap.
C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device
The affected product is the Controller Cap component only, which is provided to Terminated |
GEH | K131523 K152329 +1 |