The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bd Vacutainer Passive Shielding Blood Collection Needle.
| Device ID | K003461 |
| 510k Number | K003461 |
| Device Name: | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | M. Wendy Bosshardt |
| Correspondent | M. Wendy Bosshardt BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2001-02-01 |