Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube | SSS-LP-60 | BAYER MEDICAL CARE INC. | DXT | 00616258021904 |
| MEDRAD® Stellant Sterile Disposable Syringe | SDS-CTP-SPK | BAYER MEDICAL CARE INC. | DXT | 00616258007045 |
| MEDRAD® Stellant Sterile Disposable Syringe | SDS-CTP-QFT | BAYER MEDICAL CARE INC. | DXT | 00616258007441 |
| MEDRAD® Stellant CT Injection System | Stellant D | BAYER MEDICAL CARE INC. | DXT | 00616258021348 |
| MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe &Spike | SSS-SPK | BAYER MEDICAL CARE INC. | DXT | 00616258009902 |
| MEDRAD® Stellant CT Injection System | SSH 100F | BAYER MEDICAL CARE INC. | DXT | 00616258008899 |
| MEDRAD® Stellant Sterile Disposable Syringe | SSS-CTP-SPK | BAYER MEDICAL CARE INC. | DXT | 00616258007465 |
| MEDRAD® Stellant Sterile Disposable Syringe | SDS-CTP-SPK | BAYER MEDICAL CARE INC. | DXT | 00616258007458 |
| MEDRAD® Stellant CT Injection System | SCT121-R, SCT122-R | BAYER MEDICAL CARE INC. | DXT | 00616258010588 |
| MEDRAD® Stellant CT Injection System | Stellant SX | BAYER MEDICAL CARE INC. | DXT | 00616258010243 |
| MEDRAD® Stellant Sterile Disposable Syringe | SSS-CTP-SPK | BAYER MEDICAL CARE INC. | DXT | 00616258022185 |
| MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube | SSS-LP-60-T | BAYER MEDICAL CARE INC. | DXT | 00616258007403 |
| MEDRAD® Stellant Sterile Disposable Syringe | SDS-CTP-SCS | BAYER MEDICAL CARE INC. | DXT | 00616258005256 |
| MEDRAD® Stellant Sterile Disposable Syringe | SSS-CTP-QFT | Bayer Medical Care Inc. | DXT | 00616258024622 |
| MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube | SSS-LP-60 | BAYER MEDICAL CARE INC. | DXT | 00616258005270 |
| MEDRAD® Stellant Sterile Disposable Syringe | SSS-CTP-QFT | BAYER MEDICAL CARE INC. | DXT | 00616258005201 |
| MEDRAD® Stellant CT Injection System | Stellant D | BAYER MEDICAL CARE INC. | DXT | 00616258008912 |
| Low Pressure Connector Tubing Integral “T” with Check Valve | LP-96-T-CV | Bayer Medical Care Inc. | DXT | 00616258024431 |
| MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube | SSS-LP-60 | BAYER MEDICAL CARE INC. | DXT | 00616258007168 |
| MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube | SSS-LP-60 | BAYER MEDICAL CARE INC. | DXT | 00616258010922 |
| MEDRAD® Stellant Sterile Disposable Syringe | SSS-QFT | Bayer Medical Care Inc. | DXT | 00616258024646 |
| MEDRAD® Stellant CT Injection System | Stellant Sx | BAYER MEDICAL CARE INC. | DXT | 00616258008974 |
| MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube | SSS-LP-60 | BAYER MEDICAL CARE INC. | DXT | 00616258009971 |
| MEDRAD® Stellant Sterile Disposable Syringe | SSS-CTP-QFT | BAYER MEDICAL CARE INC. | DXT | 00616258007946 |
| MEDRAD® Stellant CT Injection System | SHS 700 05F | BAYER MEDICAL CARE INC. | DXT | 00616258008875 |