The following data is part of a premarket notification filed by Venetec, Inc. with the FDA for Statlock-ipidural.
| Device ID | K943038 |
| 510k Number | K943038 |
| Device Name: | STATLOCK-IPIDURAL |
| Classification | Set, Administration, Intravascular |
| Applicant | VENETEC, INC. 1500 QUAIL ST. SUITE 550 Newport Beach, CA 92660 |
| Contact | Patricia Amtower |
| Correspondent | Patricia Amtower VENETEC, INC. 1500 QUAIL ST. SUITE 550 Newport Beach, CA 92660 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1995-04-10 |