The following data is part of a premarket notification filed by Ivenix, Inc. with the FDA for Ivenix Infusion System, Lvp Epidural Administraion Set Nrfit Connector.
| Device ID | K213089 |
| 510k Number | K213089 |
| Device Name: | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector |
| Classification | Set, Administration, Intravascular |
| Applicant | Ivenix, Inc. 50 High St North Andover, MA 01845 |
| Contact | John Sokolowski |
| Correspondent | John Sokolowski Ivenix, Inc. 50 High St North Andover, MA 01845 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-24 |
| Decision Date | 2021-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811505030160 | K213089 | 000 |