The following data is part of a premarket notification filed by Vidacare Llc with the FDA for Ez-io Intraosseous Infusion System.
| Device ID | K141117 |
| 510k Number | K141117 |
| Device Name: | EZ-IO INTRAOSSEOUS INFUSION SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | VIDACARE LLC 4350 LOCKHILL SELMA RD. Shavano Park, TX 78249 |
| Contact | Diana F Montez, Bsn, Rn |
| Correspondent | Diana F Montez, Bsn, Rn VIDACARE LLC 4350 LOCKHILL SELMA RD. Shavano Park, TX 78249 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-30 |
| Decision Date | 2014-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816000011987 | K141117 | 000 |
| 20816000011885 | K141117 | 000 |
| 10816000011895 | K141117 | 000 |
| 20816000011908 | K141117 | 000 |
| 10816000011932 | K141117 | 000 |
| 20816000011946 | K141117 | 000 |
| 20816000011953 | K141117 | 000 |
| 20816000011960 | K141117 | 000 |
| 20816000011977 | K141117 | 000 |
| 40816000012466 | K141117 | 000 |