Cleared Traditional

K143102 - Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143102 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Gastroenterology & Urology device
Jul 2015
Decision
268d
Days
Class 2
Risk

K143102 is an FDA 510(k) clearance for the Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions. Classified as Catheter, Hemodialysis, Triple Lumen, Non-implanted (product code NIE), Class II - Special Controls.

Submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on July 24, 2015 after a review of 268 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K143102 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 29, 2014
Decision Date July 24, 2015
Days to Decision 268 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 156d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NIE Catheter, Hemodialysis, Triple Lumen, Non-implanted
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.