The following data is part of a premarket notification filed by Y with the FDA for Models: 52-01-0, 52-01-1.
| Device ID | K811110 |
| 510k Number | K811110 |
| Device Name: | MODELS: 52-01-0, 52-01-1 |
| Classification | Set, Administration, Intravascular |
| Applicant | Y 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 | 1981-04-23 |
| Decision Date | 1981-06-11 |