The following data is part of a premarket notification filed by C2 Therapeutics with the FDA for Cryoballoon Ablation System.
| Device ID | K101825 |
| 510k Number | K101825 |
| Device Name: | CRYOBALLOON ABLATION SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | C2 THERAPEUTICS 303 CONVENTION WAY SUITE 1 Redwood City, CA 94063 |
| Contact | Peter Garcia-meza |
| Correspondent | Peter Garcia-meza C2 THERAPEUTICS 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 | 2010-07-01 |
| Decision Date | 2010-09-29 |
| Summary: | summary |