The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Cryoice Cryo-ablation Probe (cryo3), Atricure Cryoice Cryoform Cryo-ablation Probe (cryof).
| Device ID | K180137 |
| 510k Number | K180137 |
| Device Name: | AtriCure CryoICE Cryo-ablation Probe (CRYO3), AtriCure CryoICE CryoFORM Cryo-ablation Probe (CRYOF) |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Contact | Melissa Smallwood |
| Correspondent | Melissa Smallwood AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-17 |
| Decision Date | 2018-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354016147 | K180137 | 000 |
| 00818354016130 | K180137 | 000 |
| 00818354017908 | K180137 | 000 |
| 00818354017892 | K180137 | 000 |
| 30840143902875 | K180137 | 000 |
| 30840143902837 | K180137 | 000 |
| 30840143902769 | K180137 | 000 |
| 30840143902721 | K180137 | 000 |