Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K181864
Polaris RF Ablation System · Baylis Medical Company, Inc. · decided 2019-01-02 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Accurian | APMT050 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000715540 |
| Accurian | APSR150 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000155216 |
| Accurian | APSC03 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000153465 |
| ACCURIAN™ | AI0003 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000312231 |
| Accurian | APSC06 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000153496 |
| Accurian | AC0019 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000153667 |
| Accurian | AC0004 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000153537 |
| Accurian | ASP001 | MEDTRONIC SOFAMOR DANEK, INC. | GXD | 00763000171216 |
| Accurian | APSD150 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000153427 |
| Accurian | APSN050 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000155223 |
| Accurian | AI0009 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000710181 |
| Accurian™ | AGSW001 | MEDTRONIC SOFAMOR DANEK, INC. | GXD GXI | 00763000405014 |
| Accurian | APSD100 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000153410 |
| Accurian | APSN150 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000155247 |
| Accurian | AC0006 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000153544 |
| ACCURIAN™ | AI0004 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000312248 |
| Accurian | AC0014 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000153636 |
| Accurian | APSD050 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000153403 |
| Accurian | AC0015 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000153643 |
| Accurian | APH100 | MEDTRONIC SOFAMOR DANEK, INC. | GXD | 00763000140823 |
| Accurian | AC0011 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000153605 |
| Accurian | ASG001 | MEDTRONIC SOFAMOR DANEK, INC. | GXD | 00763000171209 |
| ACCURIAN™ | AI0001 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000312217 |
| Accurian | APSN100 | MEDTRONIC SOFAMOR DANEK, INC. | GXI | 00763000155230 |
| Accurian | AC0017 | MEDTRONIC SOFAMOR DANEK, INC. | GEI | 20763000153650 |