The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Vacutainer Plus With Hemogard Closure.
| Device ID | K901449 |
| 510k Number | K901449 |
| Device Name: | VACUTAINER PLUS WITH HEMOGARD CLOSURE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | J Arnsberger |
| Correspondent | J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-28 |
| Decision Date | 1990-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903685870 | K901449 | 000 |
| 30382903680338 | K901449 | 000 |
| 30382903679257 | K901449 | 000 |
| 30382903679226 | K901449 | 000 |
| 50382903688840 | K901449 | 000 |
| 30382903685876 | K901449 | 000 |
| 50382903684941 | K901449 | 000 |
| 50382903676830 | K901449 | 000 |
| 50382903689212 | K901449 | 000 |
| 50382903689205 | K901449 | 000 |
| 30382903680406 | K901449 | 000 |
| 30382903678847 | K901449 | 000 |
| 30382903679219 | K901449 | 000 |
| 50382903678803 | K901449 | 000 |
| 50382903670012 | K901449 | 000 |
| 50382903666671 | K901449 | 000 |
| 30382903675877 | K901449 | 000 |
| 30382903666677 | K901449 | 000 |
| 30382903666646 | K901449 | 000 |
| 30382903678861 | K901449 | 000 |
| 30382903678809 | K901449 | 000 |
| 30382903677291 | K901449 | 000 |
| 50382903688864 | K901449 | 000 |