The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Cre Rx Biliary Balloon Dilatation Catheter.
| Device ID | K172520 |
| 510k Number | K172520 |
| Device Name: | CRE RX Biliary Balloon Dilatation Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Jia Huang |
| Correspondent | Jia Huang Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2017-10-04 |
| Summary: | summary |