Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System— 510(k) K151054
Substantially EquivalentC2 Therapeutics, Inc.
FDA 510(k) clearance K151054 for Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System, Substantially Equivalent on 2015-07-07. Applicant: C2 Therapeutics, Inc..
Clearance details
- Applicant
- C2 Therapeutics, Inc.
- Product code
- Code GEH
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood, Ca, CA, US
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.