AtriCure cryoICE Cryoablation System (CRYO3)
AtriCure cryoICE CRYO3 is a sterile, single-use cryoablation probe for treating cardiac arrhythmias during cardiac surgery. Nitrous oxide supplied through an AtriCure Cryo Module cools the…
AtriCure cryoICE CRYO3 is a sterile, single-use cryoablation probe for treating cardiac arrhythmias during cardiac surgery. Nitrous oxide supplied through an AtriCure Cryo Module cools the probe tip to freeze tissue and interrupt electrical conduction pathways.
The 4 mm diameter cryotip is malleable across its 10 cm length. A forming tool shapes it for access to the treatment site, while an insulated rigid shaft allows adjustment of the exposed therapeutic length.
Listed Item
cryoICE 10cm Cryoablation Probe
Temperature and Connections
The probe includes a handle, inlet and exhaust tubing, and a thermocouple connection to the module. The thermocouple provides real-time temperature display on the console during treatment.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Atricure, Inc., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K180137 |
| Record published | 2020-03-18 |
| Record revised | 2021-04-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box, case of 3 |
| Sizes | Length 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRYO3 | Length 10 cm | In distribution |
| CRYO3 | Length 10 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180137 | 2018-02-15 |
| K152337 | 2016-03-22 |
| K142441 | 2014-10-29 |
| K140058 | 2014-01-24 |
| K121507 | 2012-06-06 |
| K112072 | 2011-08-03 |
| K111042 | 2011-05-26 |
| K082074 | 2009-03-02 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-28 | Class II | Other | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations | 1 | |
| 2023-11-28 | Class II | Other | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations | 35 | |
| 2014-11-21 | Class II | Packaging process control | Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier. | 19,190 units | 2015-07-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.