The following data is part of a premarket notification filed by Y with the FDA for Ivac 59 Series Universal Set W/ Anti-free Flow Val.
| Device ID | K925228 |
| 510k Number | K925228 |
| Device Name: | IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL |
| Classification | Set, Administration, Intravascular |
| Applicant | Y 10300 CAMPUS POINT DR. San Diego, CA 92121 -1579 |
| Contact | Jennifer S Hankard |
| Correspondent | Jennifer S Hankard Y 10300 CAMPUS POINT DR. San Diego, CA 92121 -1579 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-16 |
| Decision Date | 1993-07-30 |