The following data is part of a premarket notification filed by Boston Scientific/medi-tech with the FDA for Flexima Biliary Catheter.
| Device ID | K023870 |
| 510k Number | K023870 |
| Device Name: | FLEXIMA BILIARY CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTON SCIENTIFIC/MEDI-TECH ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Nicholas Condakes |
| Correspondent | Nicholas Condakes BOSTON SCIENTIFIC/MEDI-TECH ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-20 |
| Decision Date | 2002-12-20 |
| Summary: | summary |