Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| MEDRAD® Avanta Fluid Management Injection System | AVA 500 PEDL | Bayer Medical Care Inc. | DXT | 00616258025223 |
| MEDRAD® Avanta Multi-Patient Disposable Set | AVA 500 MPAT (Part 1 of 2) | Bayer Medical Care Inc. | DXT | 00616258024363 |
| Hand Controller Sheath | AVA 500 HCS | BAYER MEDICAL CARE INC. | DXT | 00616258005348 |
| MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible | AVA 500 SPAT L | Bayer Medical Care Inc. | DXT | 00616258024080 |
| MEDRAD® Avanta Fluid Management Injection System | Avanta | BAYER MEDICAL CARE INC. | DXT | 00616258008578 |
| MEDRAD® Avanta Fluid Management Injection System | AVA 500 PEDL | Bayer Medical Care Inc. | DXT | 00616258025216 |
| MEDRAD® Avanta Multi-Patient Disposable Syringe | AVA 500 MPAT (Part 1 of 2) | BAYER MEDICAL CARE INC. | DXT | 00616258007854 |
| MEDRAD® Avanta Footswitch | AVA 500 FTC | BAYER MEDICAL CARE INC. | DXT | 00616258025773 |
| MEDRAD® Avanta Multi-Patient Disposable Hand Controller | AVA 500 HC | BAYER MEDICAL CARE INC. | DXT | 00616258010175 |
| MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable | AVA 500 SPAT L | BAYER MEDICAL CARE INC. | DXT | 00616258010199 |
| MEDRAD® Avanta Multi-Patient Disposable Hand Controller | AVA 500 HC | BAYER MEDICAL CARE INC. | DXT | 00616258005560 |
| MEDRAD® Avanta Multi-Patient Disposable Hand Controller | AVA 500 HC | BAYER MEDICAL CARE INC. | DXT | 00616258005331 |
| MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable | AVA 500 SPAT L | BAYER MEDICAL CARE INC. | DXT | 00616258007731 |
| MEDRAD® Avanta Multi-Patient Disposable Set | AVA 500 MPAT (Part 2 of 2) | BAYER MEDICAL CARE INC. | DXT | 00616258007717 |
| MEDRAD® Avanta Multi-Patient Disposable Set | AVA 500 MPAT (Part 2 of 2) | BAYER MEDICAL CARE INC. | DXT | 00616258007472 |
| MEDRAD® Avanta Heat Maintainer, Syringe | AVA 500 SYRH | BAYER MEDICAL CARE INC. | DXT | 00616258025247 |
| MEDRAD® Avanta Multi-Patient Disposable Syringe | AVA 500 MPAT (Part 1 of 2) | BAYER MEDICAL CARE INC. | DXT | 00616258005553 |
| MEDRAD® Avanta Fluid Management Injection System | AVA 500 TABL | Bayer Medical Care Inc. | DXT | 00616258025346 |
| MEDRAD® Avanta Heat Maintainer, Syringe | AVA 500 SYRH | Bayer Medical Care Inc. | DXT | 00616258027197 |
| MEDRAD® Avanta Fluid Management Injection System | AVA 500 FTC | BAYER MEDICAL CARE INC. | DXT | 00616258008615 |
| MEDRAD® Avanta Fluid Management Injection System | AVA 500 BTLH-L | BAYER MEDICAL CARE INC. | DXT | 00616258008608 |
| Display Control Unit Sheath | AVA 500 DCOV | BAYER MEDICAL CARE INC. | DXT | 00616258005355 |
| MEDRAD® Avanta Fluid Management Injection System | AVA 500 BTLH-M | BAYER MEDICAL CARE INC. | DXT | 00616258008592 |
| MEDRAD® Avanta Fluid Management Injection System | AVA 500 SYRH | BAYER MEDICAL CARE INC. | DXT | 00616258008585 |
| MEDRAD® Avanta Single Patient Disposable Set - Angio | AVA 500 SPAT ANGIO | BAYER MEDICAL CARE INC. | DXT | 00616258007533 |