The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Cryoice Cryosphere Cryoablation Probe.
| Device ID | K182565 |
| 510k Number | K182565 |
| Device Name: | AtriCure CryoICE CryoSPHERE Cryoablation Probe |
| Classification | Device, Surgical, Cryogenic |
| Applicant | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Jonathan Mcelwee |
| Correspondent | Jonathan Mcelwee AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-18 |
| Decision Date | 2018-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354016338 | K182565 | 000 |
| 00818354016321 | K182565 | 000 |
| 30840143902929 | K182565 | 000 |
| 30840143902912 | K182565 | 000 |