The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Mustang Balloon Dialation Catheter.
| Device ID | K141597 |
| 510k Number | K141597 |
| Device Name: | MUSTANG BALLOON DIALATION CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Boston Scientific Corporation ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Melanie Raska |
| Correspondent | Melanie Raska Boston Scientific Corporation ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-08-22 |
| Summary: | summary |