Mississauga, CA · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Class II | Cardiovascular | 2 | 2026-01-18 |
| PDU | Catheter For Crossing Total Occlusions | Class II | Cardiovascular | 2 | 2025-09-11 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 1 | 2025-10-28 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-18 | K254114 | Baylis Connector Cable | DSA | Class II | Cardiovascular |
| 2025-10-28 | K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | GEI | Class II | General, Plastic Surgery |
| 2025-09-11 | K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | PDU | Class II | Cardiovascular |
| 2024-02-28 | K232562 | PowerWire Radiofrequency Guidewire Kit | PDU | Class II | Cardiovascular |
| 2023-05-30 | K230571 | RFP-100A Connector Cable (Single Use) | DSA | Class II | Cardiovascular |