The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Pigtail Ureteral Catheter Set, Sof-flex Aq Coated Pigtail Ureteral Catheter.
| Device ID | K182695 |
| 510k Number | K182695 |
| Device Name: | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Chelsea Woods |
| Correspondent | Chelsea Woods Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-06-17 |