The following data is part of a premarket notification filed by Pentax Medical, A Division Of Pentax Of America, Inc. with the FDA for C2 Cryoballoon Catheter (pear), C2 Cryoballoon (standard), C2 Cryoballoon Controller, C2 Cryoballoon Foot Pedal, C2 Cryoballoon Cartridge.
| Device ID | K190194 |
| 510k Number | K190194 |
| Device Name: | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | PENTAX Medical, A Division Of PENTAX Of America, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 |
| Contact | Gurvinder Singh Nanda |
| Correspondent | Gurvinder Singh Nanda PENTAX Medical, A Division Of PENTAX Of America, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333248445 | K190194 | 000 |