The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Timeline Venipuncture System.
| Device ID | K860609 |
| 510k Number | K860609 |
| Device Name: | TIMELINE VENIPUNCTURE SYSTEM |
| Classification | Set, Administration, Intravascular |
| Applicant | IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Contact | Phillip E Pennell |
| Correspondent | Phillip E Pennell IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-06-04 |