DeviceClearance

K203024

Substantially Equivalent

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Applicant
Pentax of America, Inc.
Product code
GEH
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
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, 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.