The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Biliary Catheter.
| Device ID | K955126 |
| 510k Number | K955126 |
| Device Name: | LMI BILIARY CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | LUCAS MEDICAL, INC. 1751 SOUTH DOUGLASS RD. Anaheim, CA 92806 |
| Contact | Daniel R Lucas |
| Correspondent | Daniel R Lucas LUCAS MEDICAL, INC. 1751 SOUTH DOUGLASS RD. Anaheim, CA 92806 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-09 |
| Decision Date | 1996-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3807FBIL400 | K955126 | 000 |
| B3805FBBIR540D0 | K955126 | 000 |
| B3806FBBIR640D0 | K955126 | 000 |
| B3807FBBIR740D0 | K955126 | 000 |
| B3803FBIL230 | K955126 | 000 |
| B3803FBIL400 | K955126 | 000 |
| B3804FBIL230 | K955126 | 000 |
| B3804FBIL400 | K955126 | 000 |
| B3805FBIL230 | K955126 | 000 |
| B3805FBIL400 | K955126 | 000 |
| B3806FBIL230 | K955126 | 000 |
| B3806FBIL400 | K955126 | 000 |
| B3807FBIL230 | K955126 | 000 |
| B3804FBBIR440D0 | K955126 | 000 |