The following data is part of a premarket notification filed by Microvasive with the FDA for Drainage Stent.
| Device ID | K834468 |
| 510k Number | K834468 |
| Device Name: | DRAINAGE STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Contact | Unknown Unknown |
| Correspondent | Unknown Unknown MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-20 |
| Decision Date | 1984-04-20 |