The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Iv Catheter And Obturator.
Device ID | K941429 |
510k Number | K941429 |
Device Name: | IV CATHETER AND OBTURATOR |
Classification | Catheter, Umbilical Artery |
Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. CALLE F. BUSTAMANTE S/N Nogales, Sonora, MX 84000 |
Contact | C. J Welle |
Correspondent | C. J Welle BECTON DICKINSON VASCULAR ACCESS, INC. CALLE F. BUSTAMANTE S/N Nogales, Sonora, MX 84000 |
Product Code | FOS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-24 |
Decision Date | 1995-01-04 |