The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard(r) Monopty(r) Disposable Core Biopsy Instrument, Bard(r) Max-core(r) Disposable Core Instrument.
| Device ID | K133948 |
| 510k Number | K133948 |
| Device Name: | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT |
| Classification | Instrument, Biopsy |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Sarah Mccartney |
| Correspondent | Sarah Mccartney BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. 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 | 2013-12-23 |
| Decision Date | 2014-02-21 |
| Summary: | summary |