The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cxi Triforce Peripheral Crossing Set.
| Device ID | K170931 |
| 510k Number | K170931 |
| Device Name: | CXI TriForce Peripheral Crossing Set |
| Classification | Catheter, Continuous Flush |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Sarah Reeves |
| Correspondent | Sarah Reeves Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-29 |
| Decision Date | 2017-11-13 |
| Summary: | summary |