The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Posiflush Heparin Lock Flush Syringe.
Device ID | K163591 |
510k Number | K163591 |
Device Name: | BD PosiFlush Heparin Lock Flush Syringe |
Classification | Heparin, Vascular Access Flush |
Applicant | Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07045 |
Contact | Aakash Jain |
Correspondent | Aakash Jain Becton Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07045 |
Product Code | NZW |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-20 |
Decision Date | 2017-02-27 |
Summary: | summary |