The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Expel Apd Drainage Catheter System.
| Device ID | K141335 |
| 510k Number | K141335 |
| Device Name: | EXPEL APD DRAINAGE CATHETER SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Matt Beauchane |
| Correspondent | Matt Beauchane BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-10-17 |
| Summary: | summary |