K183219 is an FDA 510(k) clearance for the Trio-CT Triple Lumen Catheter. This device is classified as a Catheter, Hemodialysis, Triple Lumen, Non-implanted (Class II - Special Controls, product code NIE).
Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on June 14, 2019, 206 days after receiving the submission on November 20, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540. Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion..
| 510(k) Number | K183219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | November 20, 2018 |
| Decision Date | June 14, 2019 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NIE — Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion. |