The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Imajin Silicone Double Loop Ureteral Stent Kits, Imajin Pyelostent Silicone Double Loop Ureteral Stent Kits, Imajin Stenostent Silicone Double Loop Ureteral Stent Kits.
| Device ID | K213185 |
| 510k Number | K213185 |
| Device Name: | ImaJin Silicone Double Loop Ureteral Stent Kits, ImaJin Pyelostent Silicone Double Loop Ureteral Stent Kits, ImaJin Stenostent Silicone Double Loop Ureteral Stent Kits |
| Classification | Stent, Ureteral |
| Applicant | Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Gayatri Ghadge |
| Correspondent | Gayatri Ghadge Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-06-08 |