The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Arrow Epidural Needle Kz-05500-007(luer); Kz-05500-009 (nrfit).
| Device ID | K190026 |
| 510k Number | K190026 |
| Device Name: | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Lakshmi Kanuri |
| Correspondent | Lakshmi Kanuri Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-07 |
| Decision Date | 2019-08-21 |