510(k) K180137
K180137 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)". The FDA issued a decision of Substantially Equivalent on Feb 15, 2018. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. AtriCure, Inc. has 58 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 15, 2018
- Date Received
- Jan 17, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type
- 510(k)