The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Ultra-vue Procedure Needle W/ Spinal Type Pt..
| Device ID | K915480 |
| 510k Number | K915480 |
| Device Name: | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. |
| Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| 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 | DWD |
| CFR Regulation Number | 870.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-06 |
| Decision Date | 1992-01-07 |