The following data is part of a premarket notification filed by Tico Medical Instruments, Inc. with the FDA for Retrograde Infusion Set 3ml & 6ml-.
| Device ID | K840443 |
| 510k Number | K840443 |
| Device Name: | RETROGRADE INFUSION SET 3ML & 6ML- |
| Classification | Set, Administration, Intravascular |
| Applicant | TICO MEDICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-04-17 |