The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard Mission Disposable Core Biopsy Instrument.
| Device ID | K171953 |
| 510k Number | K171953 |
| Device Name: | Bard Mission Disposable Core Biopsy Instrument |
| Classification | Instrument, Biopsy |
| Applicant | Bard Peripheral Vascular, Inc. 1625 W 3rd St. Tempe, AZ 85281 |
| Contact | Susan Sheffield |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-29 |
| Decision Date | 2017-09-14 |
| Summary: | summary |