The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Imager Ii Urology Torque Catheter.
| Device ID | K180530 |
| 510k Number | K180530 |
| Device Name: | Imager II Urology Torque Catheter |
| Classification | Catheter, Urological |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Daniel Fitzdaniel |
| Correspondent | Daniel Fitzdaniel Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-28 |
| Decision Date | 2018-04-10 |
| Summary: | summary |