The following data is part of a premarket notification filed by Bard Peripheral Vascular with the FDA for Elevation Breast Biopsy System.
| Device ID | K211933 |
| 510k Number | K211933 |
| Device Name: | EleVation Breast Biopsy System |
| Classification | Instrument, Biopsy |
| Applicant | Bard Peripheral Vascular 1625 W. 3rd Street Tempe, AZ 85281 |
| Contact | Meghan Mckelvey |
| Correspondent | Meghan Mckelvey Bard Peripheral Vascular 1625 W. 3rd Street Tempe, AZ 85281 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-22 |
| Decision Date | 2021-07-15 |