The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Vacutainer Ultratouch Push Button Blood Collection Set.
| Device ID | K153309 |
| 510k Number | K153309 |
| Device Name: | BD Vacutainer UltraTouch Push Button Blood Collection Set |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07417 |
| Contact | Pasquale Amato |
| Correspondent | Pasquale Amato BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07417 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-17 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903673938 | K153309 | 000 |
| 50382903673921 | K153309 | 000 |
| 50382903673914 | K153309 | 000 |
| 50382903673655 | K153309 | 000 |
| 50382903673648 | K153309 | 000 |
| 50382903673631 | K153309 | 000 |