The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Timleine(tm) Venipuncture System.
| Device ID | K870770 |
| 510k Number | K870770 |
| Device Name: | TIMLEINE(TM) VENIPUNCTURE SYSTEM |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Contact | Pennell |
| Correspondent | Pennell IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-04-23 |