Cleared Traditional

K173805 - 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) (FDA 510(k) Clearance)

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

K173805 · Marvao Medical Devices, Ltd. · Gastroenterology & Urology device

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Optimized for regulatory review, auditing and printing

Feb 2018

Decision

55d

Days

Class 2

Risk

K173805 is an FDA 510(k) clearance for the NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexS.... 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 February 8, 2018 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marvao Medical Devices, Ltd. devices

Submission Details

510(k) Number	K173805 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	December 15, 2017
Decision Date	February 08, 2018
Days to Decision	55 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

75d faster than avg

Panel avg: 130d · This submission: 55d

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.