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 |