The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex, Inc.) with the FDA for Ez-io Intraosseous Vascular Access System.
| Device ID | K180395 |
| 510k Number | K180395 |
| Device Name: | EZ-IO Intraosseous Vascular Access System |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Arrow International, Inc. (Subsidiary Of Teleflex, Inc.) 2400 Bernville Road Reading, PA 19605 |
| Contact | Frank Pelc |
| Correspondent | Frank Pelc Arrow International, Inc. (Subsidiary Of Teleflex, Inc.) 2400 Bernville Road Reading, PA 19605 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-13 |
| Decision Date | 2018-11-09 |
| Summary: | summary |