The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Roadrunner Pc Wire Guide, Olcott Torque Device.
| Device ID | K182985 |
| 510k Number | K182985 |
| Device Name: | Roadrunner PC Wire Guide, Olcott Torque Device |
| Classification | Wire, Guide, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Daniel J. Corbin |
| Correspondent | Daniel J. Corbin Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-29 |
| Decision Date | 2019-07-22 |
| Summary: | summary |