The following data is part of a premarket notification filed by Venetec, Inc. with the FDA for Statlock Cv.
| Device ID | K943147 |
| 510k Number | K943147 |
| Device Name: | STATLOCK CV |
| Classification | Device, Intravascular Catheter Securement |
| 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 | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-30 |
| Decision Date | 1994-09-29 |