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)

K143567 is an FDA 510(k) clearance for NexSite HD Hemodialysis Split Tip Cathe..., 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 105-day FDA review.

K143567 · Marvao Medical Devices, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Marvao Medical Devices, Ltd. devices

FDA 510(k) Submission Details - K143567

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 131d · This submission: 105d
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
CHRISTINE NICHOLS

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 120
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K143567.
Symetrex Long Term Hemodialysis Catheter
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NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
K161026 · Marvao Medical Devices, Ltd. · Aug 2016
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
K151967 · Merit Medical Systems, Inc. · Apr 2016
SYMETREX LONG TERM HEMODIALYSIS CATHETER
K140884 · Phase One Medical · Nov 2014
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
K140492 · Marvao Medical Devices, Ltd. · Nov 2014
VECTORFLOW
K141051 · Arrow International, Inc. · Jul 2014