The following data is part of a premarket notification filed by Bard Access Systems, Inc, (c.r. Bard, Inc.) with the FDA for Bd Prevue Ii Peripheral Vascular Vascular Access System.
| Device ID | K211193 |
| 510k Number | K211193 |
| Device Name: | BD Prevue II Peripheral Vascular Vascular Access System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Bard Access Systems, Inc, (C.R. Bard, Inc.) 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Fabio De Pasquale |
| Correspondent | Fabio De Pasquale Bard Access Systems, Inc, (C.R. Bard, Inc.) 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-21 |
| Decision Date | 2021-06-25 |