The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Silicone Peripherally Inserted Central Venous Catheter Set/tray.
| Device ID | K171994 |
| 510k Number | K171994 |
| Device Name: | Silicone Peripherally Inserted Central Venous Catheter Set/Tray |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Johnathan Liu |
| Correspondent | Johnathan Liu Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2018-02-22 |
| Summary: | summary |