The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Vacutainer Eclipse Ultrafill Blood Collection Needle.
| Device ID | K181730 |
| 510k Number | K181730 |
| Device Name: | BD Vacutainer Eclipse UltraFill Blood Collection Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Eileen Hiller |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-29 |
| Decision Date | 2019-03-01 |
| Summary: | summary |