The following data is part of a premarket notification filed by Microvasive with the FDA for Needle W/stylet For Implantation.
| Device ID | K854238 |
| 510k Number | K854238 |
| Device Name: | NEEDLE W/STYLET FOR IMPLANTATION |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Contact | Samuel D Wade |
| Correspondent | Samuel D Wade MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1985-11-13 |