The following data is part of a premarket notification filed by B. Braun Instruments with the FDA for Catheter, Vein (venofix).
Device ID | K760388 |
510k Number | K760388 |
Device Name: | CATHETER, VEIN (VENOFIX) |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | B. BRAUN INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-05 |
Decision Date | 1976-11-02 |