The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608.
| Device ID | K982541 |
| 510k Number | K982541 |
| Device Name: | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | Andrea Hroncich |
| Correspondent | Andrea Hroncich BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-21 |
| Decision Date | 1998-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903686518 | K982541 | 000 |
| 50382903686105 | K982541 | 000 |
| 00382903686506 | K982541 | 000 |
| 00382903686513 | K982541 | 000 |
| 30382903686071 | K982541 | 000 |
| 30382903686088 | K982541 | 000 |
| 10193489699326 | K982541 | 000 |
| 10889942229529 | K982541 | 000 |
| 10889942540495 | K982541 | 000 |
| 10889942712267 | K982541 | 000 |
| 50382903686075 | K982541 | 000 |
| 50382903686082 | K982541 | 000 |
| 50382903686501 | K982541 | 000 |
| 50382903686099 | K982541 | 000 |