The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Cryo1 Cryo-ablation Probe.
| Device ID | K082074 |
| 510k Number | K082074 |
| Device Name: | ATRICURE CRYO1 CRYO-ABLATION PROBE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ATRICURE, INC. 6033 SCHUMACHER PARK DR. West Chester, OH 45069 |
| Contact | James Lucky |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2009-03-02 |
| Summary: | summary |