Cleared Traditional

K161026 - NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)

K161026 is an FDA 510(k) clearance for NexSite HD Hemodialysis Step Tip Cathet..., manufactured by Marvao Medical Devices, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K161026 · Marvao Medical Devices, Ltd. · Gastroenterology & Urology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Aug 2016

Decision

119d

Days

Class 2

Risk

K161026 is an FDA 510(k) clearance for the NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 3.... 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 August 9, 2016 after a review of 119 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.

FDA 510(k) Submission Details - K161026

510(k) Number	K161026 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	April 12, 2016
Decision Date	August 09, 2016
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

12d faster than avg

Panel avg: 131d · This submission: 119d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Boston Biomedical Associates

Joseph DePaolo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MSD Catheter, Hemodialysis, Implanted

All 123

Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K161026.

NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)

K173805 · Marvao Medical Devices, Ltd. · Feb 2018

NexSite HD, Hemodialysis Step Tip Catheter (60cm)

K171571 · Marvao Medical Devices, Ltd. · Nov 2017

Symetrex Long Term Hemodialysis Catheter

K171618 · Medcomp (Dba Medical Components, Inc.) · Nov 2017

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter

K151967 · Merit Medical Systems, Inc. · Apr 2016

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)

K143567 · Marvao Medical Devices, Ltd. · Mar 2015

SYMETREX LONG TERM HEMODIALYSIS CATHETER

K140884 · Phase One Medical · Nov 2014

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.