C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge— 510(k) K190194
Substantially EquivalentPentax Medical, A Division of Pentax of America, Inc.
FDA 510(k) clearance K190194 for C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge, Substantially Equivalent on 2019-05-31. Applicant: Pentax Medical, A Division of Pentax of America, Inc..
Clearance details
- Applicant
- Pentax Medical, A Division of Pentax of America, Inc.
- Product code
- Code GEH
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.