The following data is part of a premarket notification filed by Bard Access Systems with the FDA for Bd Intraosseous Vascular Access System Ems Powered Driver (d001003).
| Device ID | K223198 |
| 510k Number | K223198 |
| Device Name: | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) |
| Classification | Needle, Interosseous |
| Applicant | Bard Access Systems 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Nasreen Al-Quaid |
| Correspondent | Nasreen Al-Quaid Bard Access Systems 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | MHC |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-13 |
| Decision Date | 2022-11-10 |