The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Brite Tip Radianz Guiding Sheath.
| Device ID | K202167 |
| 510k Number | K202167 |
| Device Name: | Brite Tip Radianz Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | Cordis Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
| Contact | Crystal Placona |
| Correspondent | Crystal Placona Cordis Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2021-02-26 |