The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Arterial Blood Containment Device.
Device ID | K925947 |
510k Number | K925947 |
Device Name: | B-D ARTERIAL BLOOD CONTAINMENT DEVICE |
Classification | Wire, Guide, Catheter |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Russell Arnsberger |
Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | DQX |
Subsequent Product Code | FOX |
Subsequent Product Code | FOZ |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-24 |
Decision Date | 1993-08-20 |