The following data is part of a premarket notification filed by Atricure, Inc with the FDA for Cryoform Cryoice Cryoablation Probe.
| Device ID | K152337 |
| 510k Number | K152337 |
| Device Name: | CryoFORM CryoICE Cryoablation Probe |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ATRICURE, INC 6217 CENTRE PARK DR West Chester, OH 45069 |
| Contact | Jonathan Mcelwee |
| 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 | 2015-08-19 |
| Decision Date | 2016-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354014839 | K152337 | 000 |