The following data is part of a premarket notification filed by C2 Therapeutics, Inc. with the FDA for Coldplay Full Cryoballoon Ablation System And Coldplay Swipe Cryoballoon Ablation System.
| Device ID | K151054 |
| 510k Number | K151054 |
| Device Name: | Coldplay Full CryoBalloon Ablation System And Coldplay Swipe CryoBalloon 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-07-07 |
| Summary: | summary |