Device Listing 2018893502
Listing Summary#
- Listing key
- 2018893502
- Premarket submission
- K190194
- Device
- C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- Applicant
- Pentax Medical, A Division of Pentax of America, Inc.
- Product code
- GEH
- Decision date
- 2019-05-31