The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for First Picc Introducer Catheter.
Device ID | K954906 |
510k Number | K954906 |
Device Name: | FIRST PICC INTRODUCER CATHETER |
Classification | Introducer, Catheter |
Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | C J Welle |
Correspondent | C J Welle BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-25 |
Decision Date | 1996-04-08 |
Summary: | summary |