The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Corvocet Biopsy System.
| Device ID | K180450 |
| 510k Number | K180450 |
| Device Name: | Corvocet Biopsy System |
| Classification | Instrument, Biopsy |
| Applicant | Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
| Contact | Angela Brady |
| Correspondent | Angela Brady Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-03-12 |
| Summary: | summary |