The following data is part of a premarket notification filed by Atricure Inc. with the FDA for Atricure Cryoice Cryo-ablation Probe (cryo2), Aatricure Cryoice Cryosphere Cryoablation Probe (cryos, Cryos-l).
| Device ID | K200697 |
| 510k Number | K200697 |
| Device Name: | AtriCure CryoICE Cryo-ablation Probe (Cryo2), AAtriCure CryoICE CryoSPHERE Cryoablation Probe (CryoS, CryoS-L) |
| Classification | Device, Surgical, Cryogenic |
| 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 | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-17 |
| Decision Date | 2020-12-23 |