The following data is part of a premarket notification filed by Cook Vascular Inc. with the FDA for Cook Vascular Vital-ject Power Injectable Safety Infusion Set.
| Device ID | K083482 |
| 510k Number | K083482 |
| Device Name: | COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | COOK VASCULAR INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Contact | Jim Ferguson, Jr. |
| Correspondent | Jim Ferguson, Jr. COOK VASCULAR INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-04-02 |
| Summary: | summary |