The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Ez-io.
| Device ID | K052408 |
| 510k Number | K052408 |
| Device Name: | EZ-IO |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-01 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EZ-IO 87211623 5269420 Live/Registered |
Teleflex Medical Devices S.Ã r.l. 2016-10-21 |
![]() EZ-IO 85499983 4183350 Dead/Cancelled |
TELEFLEX MEDICAL DEVICES S.Ã R.L. 2011-12-20 |
![]() EZ-IO 78405834 2984250 Dead/Cancelled |
VIDACARE LLC 2004-04-21 |