Cleared Traditional

K143567 - NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) (FDA 510(k) Clearance)

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

K143567 · Marvao Medical Devices, Ltd. · Gastroenterology & Urology device

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Mar 2015

Decision

105d

Days

Class 2

Risk

K143567 is an FDA 510(k) clearance for the NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite .... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Marvao Medical Devices, Ltd. (Galway, IE). The FDA issued a Cleared decision on March 31, 2015 after a review of 105 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number	K143567 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	December 16, 2014
Decision Date	March 31, 2015
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

25d faster than avg

Panel avg: 130d · This submission: 105d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	MSD Catheter, Hemodialysis, Implanted
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 876.5540

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.