C2 Therapeutics, Inc. · Class II · Cleared Apr 13, 2016
| K-number | K152329 |
| Device name | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System |
| Applicant | C2 Therapeutics, Inc. |
| Product code | GEH |
| Device class | Class II |
| Decision date | Apr 13, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 878.4350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov