Coldplay CryoBalloon® Ablation System
Unit, Cryosurgical, Accessories
C2 THERAPEUTICS, INC.
The following data is part of a premarket notification filed by C2 Therapeutics, Inc. with the FDA for Coldplay Cryoballoon® Ablation System.
Pre-market Notification Details
| Device ID | K153541 |
| 510k Number | K153541 |
| Device Name: | Coldplay 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 | 2015-12-10 |
| Decision Date | 2016-01-07 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854924006323 | K153541 | 000 |
Trademark Results [Coldplay CryoBalloon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLDPLAY CRYOBALLOON 86639028 not registered Dead/Abandoned |
C2 Therapeutics, Inc. 2015-05-22 |
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