The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Angiocath Sideholder Drainage Catheter.
Device ID | K950437 |
510k Number | K950437 |
Device Name: | ANGIOCATH SIDEHOLDER DRAINAGE CATHETER |
Classification | Catheter, Irrigation |
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 | GBX |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-02 |
Decision Date | 1995-03-14 |