The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Black Silicone Filiform Double Pigtail Stent Set.
| Device ID | K172017 |
| 510k Number | K172017 |
| Device Name: | Black Silicone Filiform Double Pigtail Stent Set |
| Classification | Stent, Ureteral |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Karthik Pillai |
| Correspondent | Karthik Pillai Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2018-03-26 |
| Summary: | summary |