The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Angiolapcath Cholangiography Kit.
Device ID | K926143 |
510k Number | K926143 |
Device Name: | ANGIOLAPCATH CHOLANGIOGRAPHY KIT |
Classification | Catheter, Cholangiography |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Marcia C Leatham |
Correspondent | Marcia C Leatham BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-07 |
Decision Date | 1993-07-07 |