Pentax Medical, A Division of Pentax of America, Inc.
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories2
Latest FDA decision2019-11-22
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K193036 | C2 CryoBalloon EndoGrip | OCX | 2019-11-22 | View |
| 510(k) | K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | GEH | 2019-05-31 | View |
No matching devices.