Medtronic, Inc. · Class II · Cleared Mar 28, 2024
| K-number | K233838 |
| Device name | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B) |
| Applicant | Medtronic, Inc. |
| Product code | NEY |
| Device class | Class II |
| Decision date | Mar 28, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
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