The following data is part of a premarket notification filed by Np Medical with the FDA for Np Medical Ncompass Extension Set With Stabilizing Base.
| Device ID | K221518 |
| 510k Number | K221518 |
| Device Name: | NP Medical NCompass Extension Set With Stabilizing Base |
| Classification | Set, Administration, Intravascular |
| Applicant | NP Medical 101 Union Street Clinton, MA 01510 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan NP Medical 101 Union Street Clinton, MA 01510 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-25 |
| Decision Date | 2022-11-03 |