The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Radiance(tm) Clear Sharklet(r) Silicone Foley Catheter.
| Device ID | K173657 |
| 510k Number | K173657 |
| Device Name: | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | Samuel Engelman |
| Correspondent | Chelsea Woods Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-29 |
| Decision Date | 2018-08-23 |
| Summary: | summary |