K171994 is an FDA 510(k) clearance for the Silicone Peripherally Inserted Central Venous Catheter Set/Tray. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 22, 2018, 234 days after receiving the submission on July 3, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K171994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2017 |
| Decision Date | February 22, 2018 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |