C2 Therapeutics, Inc.
FDA Regulatory Profile
C2 Therapeutics, Inc. appears in FDA public data with 1 recall, 10 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1477-2017, Class II) was initiated on January 6, 2017. Its most recent 510(k) clearance was granted on January 23, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1477-2017 | Class II | C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryo | January 6, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163684 | C2 CryoBalloon Ablation System | January 23, 2018 |
| K161202 | C2 Cryoballoon Ablation System | January 5, 2017 |
| K160994 | C2 CryoBalloon Focal Pear Catheter | May 19, 2016 |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | April 13, 2016 |
| K153541 | Coldplay CryoBalloon® Ablation System | January 7, 2016 |
| K152140 | Boa Endoscopic Valve | October 13, 2015 |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System | July 7, 2015 |
| K150083 | Sidecar External Working Channel | April 14, 2015 |
| K131523 | CRYOBALLOON FOCAL ABLATION SYSTEM | August 22, 2013 |
| K101825 | CRYOBALLOON ABLATION SYSTEM | September 29, 2010 |