The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Cryoice Croablation Probe.
| Device ID | K142441 |
| 510k Number | K142441 |
| Device Name: | CryoICE Croablation Probe |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ATRICURE, INC. 6217 CENTER PARK DRIVE West Chester, OH 45069 |
| Contact | Jonathan Mcelwee |
| Correspondent | Jonathan Mcelwee ATRICURE, INC. 6217 CENTER PARK DRIVE West Chester, OH 45069 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2014-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354014549 | K142441 | 000 |