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 |