The following data is part of a premarket notification filed by Venetec, Inc. with the FDA for Statlock Securement Devices.
| Device ID | K942931 |
| 510k Number | K942931 |
| Device Name: | STATLOCK SECUREMENT DEVICES |
| Classification | Set, Administration, Intravascular |
| Applicant | VENETEC, INC. 5310 WARD ROAD, SUITE G-07 Arvada, CO 80002 |
| Contact | Patricia Amtower |
| Correspondent | Patricia Amtower VENETEC, INC. 5310 WARD ROAD, SUITE G-07 Arvada, CO 80002 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-22 |
| Decision Date | 1995-03-28 |