The following data is part of a premarket notification filed by Pacific Device, Inc. with the FDA for Intravascular Administration Sets.
| Device ID | K912860 |
| 510k Number | K912860 |
| Device Name: | INTRAVASCULAR ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
| Contact | Jim Caputo |
| Correspondent | Jim Caputo PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-27 |
| Decision Date | 1991-08-28 |