The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Rubicon 14, 18 And 35 Support Catheters.
| Device ID | K171913 |
| 510k Number | K171913 |
| Device Name: | Rubicon 14, 18 And 35 Support Catheters |
| Classification | Catheter, Percutaneous |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Ka Zoua Xiong |
| Correspondent | Ka Zoua Xiong Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2017-07-25 |
| Summary: | summary |