Cleared Traditional

Trio-CT?? Triple Lumen Catheter w/ Curved Extensions

K232945 · Medical Components, Inc. (dba MedComp) · Gastroenterology & Urology

Nov 2023

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K232945 is an FDA 510(k) clearance for the Trio-CT?? Triple Lumen Catheter w/ Curved Extensions, 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 November 16, 2023, 57 days after receiving the submission on September 20, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K232945 FDA.gov
FDA Decision	Cleared SESK
Date Received	September 20, 2023
Decision Date	November 16, 2023
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

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.