The following data is part of a premarket notification filed by Pentaferte Italia S.r.l. with the FDA for Pentaflush.
| Device ID | K214080 |
| 510k Number | K214080 |
| Device Name: | Pentaflush |
| Classification | Saline, Vascular Access Flush |
| Applicant | PENTAFERTE ITALIA S.R.L. Viale Piane Nocella, 23 Campli Teramo, IT 64012 |
| Contact | Rosa Di Gioia |
| Correspondent | Luca Giustini PQE US 12300 Twinbrook Parkway, Suite 400 4th Floor Rockville, MD 20852 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-07-20 |