The following data is part of a premarket notification filed by C2 Therapeutics, Inc. with the FDA for Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System.
| Device ID | K152329 |
| 510k Number | K152329 |
| Device Name: | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | C2 Therapeutics, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 |
| Contact | Theresa Brandner-allen |
| Correspondent | Theresa Brandner-allen C2 Therapeutics, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-18 |
| Decision Date | 2016-04-13 |
| Summary: | summary |