The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Cryo Module System; Cryoice Cryoablation Probe.
| Device ID | K142203 |
| 510k Number | K142203 |
| Device Name: | Atricure Cryo Module System; CryoICE Cryoablation Probe |
| Classification | Device, Surgical, Cryogenic |
| Applicant | ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
| Contact | Jonathan Mcelwee |
| Correspondent | Jonathan Mcelwee ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354012705 | K142203 | 000 |
| 10840143902949 | K142203 | 000 |
| 10840143902932 | K142203 | 000 |
| 10840143902925 | K142203 | 000 |