C2 CryoBalloon Focal Pear Catheter— 510(k) K160994

Substantially Equivalent

C2 Therapeutics, Inc.

FDA 510(k) clearance K160994 for C2 CryoBalloon Focal Pear Catheter, Substantially Equivalent on 2016-05-19. Applicant: C2 Therapeutics, Inc..

Clearance details

Applicant: C2 Therapeutics, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2016-04-08
Decision date: 2016-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood, Ca, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.