The following data is part of a premarket notification filed by Numed, Inc. with the FDA for D'vill Introducer.
| Device ID | K190974 |
| 510k Number | K190974 |
| Device Name: | D'Vill Introducer |
| Classification | Introducer, Catheter |
| Applicant | NuMED, Inc. 2880 Main Street Hopkinton, NY 12965 |
| Contact | Nichelle Laflesh |
| Correspondent | Nichelle Laflesh NuMED, Inc. 2880 Main Street Hopkinton, NY 12965 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2019-05-14 |
| Summary: | summary |